Post Operative PainTRACENCT07680998
Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery
A study testing Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol in people with Post Operative Pain and Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Chronic Pain
- What is being tested?
- Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for outpatient surgery.
- Patients undergoing surgery likely to result in moderate to severe pain.
- Patients available for a 3-month follow-up.
- Patients who have provided their free and informed consent.
- Patients who have signed the consent form.
- Patients enrolled in or covered by a health insurance plan.
Who cannot join
- Patients participating in an interventional RIPH study involving a drug or classified as Category 1.
- Patients in an exclusion period determined by another study.
- Patients under judicial protection, guardianship, or conservatorship.
- Patients unable to express consent.
- Patient for whom it is impossible to provide informed information.
- Pregnant, laboring, or breastfeeding patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nimes University Hospital
Nîmes, Gard, 30029
Nimes U Hospital, Dr., +334.66.68.30.50, joel.lhermite@chu-nimes.fr
Anissa MEGZARI, +33466684236, drc@chu-nimes.fr
About this study
Official title: Evaluation of the Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery - A Single-Center, Randomized, Controlled Proof-of-Concept Study.
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality. Poorly controlled APOP is a major risk factor for chronic postoperative pain. In France today, more and more patients undergo surgical procedures as outpatients. The challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either after outpatient surgery or after a prompt return home as part of an Enhanced Recovery After Surgery (ERAS) protocol. In outpatient surgery, postoperative pain management requires new strategies and/or organizational approaches to ensure high-quality pain management from the very start. The principle of analgesia for acute postoperative pain recommends: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy if maintenance therapy is insufficient, based on pain titration, using mild or strong oral opioids. Postoperative pain is the primary focus of postoperative care but the goal is also to improve postoperative recovery and enhance the patient's overall care. To date, there are no medical telemonitoring devices to support the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, enabling systematic postoperative screening for early and late warning signs of the risk of chronic pain. The Thess Monitoring device, which implements the ANTALGEEK® protocol, (TMA) was developed to optimize the efficiency of outpatient management of acute postoperative pain. It improves patients' adherence to maintenance treatment with adaptive, personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing). The aim is to ensure optimal pain resolution and improve early and late postoperative recovery during the first postoperative week. The TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain. By measuring pain scores daily during the first postoperative week, it identifies patients with a suboptimal pain trajectory who are at high risk of developing persistent pain beyond the third month. It also assesses warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3). Improving the patient care pathway via the TMA system should make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
Read the detailed description
The problem of acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year and potentially leading to numerous complications when inadequately managed. In the postoperative period, the implementation of effective analgesic therapy is a key factor in reducing early postoperative morbidity and mortality. Furthermore, poorly controlled PPS is one of the major risk factors for the development of chronic postoperative pain (CPOP). Optimizing analgesic medication to prevent an abnormal pain trajectory during the first postoperative week is a key strategy for preventing chronic postoperative pain.
Today, within the French healthcare system, an increasing number of patients undergo surgical procedures performed on an outpatient basis. The big challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either following outpatient surgery or after an early return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.
In outpatient surgery, improving postoperative pain management requires the implementation of new strategies and/or organizational approaches to ensure a high-quality pain management pathway from the very beginning.
The principle of analgesia for acute postoperative pain recommends a combination of: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy-if maintenance therapy is insufficient-based on the principle of pain titration, using oral opioids (mild or strong). While postoperative pain remains the primary focus of postoperative care, the goal is also to improve postoperative recovery more broadly and thereby enhance the patient's overall care.
The assessment of postoperative recovery in outpatient surgery patients using a medical telemonitoring device is associated with a reduction in discomfort caused by various postoperative symptoms, including postoperative pain. However, to date, there is no medical telemonitoring device that both supports the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, and enables systematic postoperative screening for early and late warning signs of the risk of chronic pain.
To this end, the Thess Monitoring medical telemonitoring device (which implements the ANTALGEEK® protocol) (TMA) was developed. It is a tool for continuous therapeutic support and postoperative telemonitoring designed to optimize the efficiency of outpatient management of acute postoperative pain in patients by improving adherence to maintenance therapy, adaptive and personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing), with the goal of ensuring optimal pain resolution and improved early and late postoperative recovery during the first postoperative week (Baseline-Day 7). To achieve this, the TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain: identify, through daily measurement of pain scores during the first postoperative week, patients with a suboptimal pain trajectory who are at high risk of developing persistent postoperative pain beyond the third month; assess warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3).
Improving the patient care pathway through the TMA system should thus make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
In this initial proof-of-concept study, the investigators aim to evaluate the performance and safety of the TMA medical device in the outpatient management of acute pain during the first postoperative week, as well as its impact on postoperative recovery and on reducing the risk of pain becoming chronic by the third postoperative month.
- Conditions
- Post Operative Pain, Chronic Pain
- Being tested
- Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol
- Keywords
- Post Operative Pain, Pain Management, Monitoring
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocolDevice
The Thess monitoring medical device (Thess Corp., Montpellier) uses the remote ANTALGEEK® telemonitoring protocol to manage pain in outpatients who have had surgery causing moderate-to-severe pain. It digitalizes and optimizes acute postoperative pain management at home by improving adherence to maintenance therapy, with adaptive, tailored control of analgesia through better use of opioid rescue therapy to reduce the adverse effects of opioid misuse and ensures optimal pain resolution and postoperative recovery during the first week. The ANTALGEEK decision-making algorithm and a medical telemonitoring protocol help patients follow their pain medication regimen, monitoring them in postoperative Week 1, based on the preoperative prescription, data on the patient's adherence to treatment, its efficacy and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative pain management : standard care | No intervention | Patients receiving standard postoperative analgesic care |
| Postoperative pain management using the Thess telemonitoring device | Experimental | Patients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol Receives: Device: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 2
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 2
Secondary outcomes (105)
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 7
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Measured: Day 7
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 1
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 2
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 3
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 4
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 5
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 6
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 7
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 1
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 2
Pain progression in the experimental group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 3
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 1
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 2
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 3
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 4
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 5
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 6
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Day 7
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 1
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 2
Pain progression in the in the standard care (control) group
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
Measured: Month 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Baseline
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Baseline
rate of adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group
Phone call from the patient
Measured: Day 1
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 2
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 2
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 4
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 4
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 5
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 5
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 6
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 6
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Patient's declaration in the Thess Monitoring Application
Measured: Day 7
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Phone call from the patient
Measured: Day 7
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Baseline
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Baseline
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 1
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 1
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 2
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 2
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 3
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 3
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 4
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 4
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 5
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 5
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 6
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 6
Incidence of adverse effects associated with opioid use in the experimental group
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 7
Incidence of adverse effects associated with opioid use in the standard care (control) group
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
Measured: Day 7
Adverse Events [Safety and Tolerability] in the experimental group
Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.
Measured: Day 7
Adverse Events [Safety and Tolerability]in the standard care (control) group
Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.
Measured: Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application
Measured: Day 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form
Measured: Day 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application
Measured: Day 2
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form
Measured: Day 2
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application
Measured: Day 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form
Measured: Day 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
Measured: Day 4
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form
Measured: Day 4
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
Measured: Day 5
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form
Measured: Day 5
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application
Measured: Day 6
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form
Measured: Day 6
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application
Measured: Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form
Measured: Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient
Measured: Month 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient
Measured: Month 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient
Measured: Month 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient
Measured: Month 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Data collection via the Tess Monitoring Application
Measured: Day 1
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Data collection on the electronic clinical registration form
Measured: Day 1
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Data collection via the Tess Monitoring Application
Measured: Day 2
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Data collection on the electronic clinical registration form
Measured: Day 2
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Data collection via the Tess Monitoring Application
Measured: Day 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Data collection on the electronic clinical registration form
Measured: Day 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Data collection via the Tess Monitoring Application
Measured: Day 4
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Data collection on the electronic clinical registration form
Measured: Day 4
Prescription issued outside of those prescribed upon hospital discharge in the experimental group
Quantitative
Measured: Month 3
Prescription issued outside of those prescribed upon hospital discharge in the standard care(control) group
Quantitative
Measured: Month 3
Number of days of sick leave prescribed in the experimental group
Quantitative
Measured: Month 3
Number of days of sick leave prescribed in the standard care (control) group
Quantitative
Measured: Month 3
Satisfaction questionnaire administered to the patient in the experimental group
Qualitative
Measured: Day 3
Satisfaction questionnaire administered to the patient in the standard care (control) group
Qualitative
Measured: Day 3
Satisfaction questionnaire administered to the anesthesiologist in the experimental group
Qualitative
Measured: End of the inclusion period
Satisfaction questionnaire administered to the anesthesiologist in the standard care (control) group
Qualitative
Measured: End of the inclusion period
System Usability Scale score during the follow-up call to patients in the experimental group
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.
Measured: Day 30
System Usability Scale score from health providers to the experimental group
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.
Measured: End of the inclusion period
System Usability Scale score during the follow-up call to patients in the standard care (control) group
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.
Measured: Day 30
System Usability Scale score from health providers to the standard care (control) group
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.
Measured: End of the inclusion period
DN2 questionnaire score in the experimental group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 1
DN2 questionnaire score in the experimental group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 2
DN2 questionnaire score in the experimental group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 3
DN2 questionnaire score in the standard care (control) group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 1
DN2 questionnaire score in the standard care (control) group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 2
DN2 questionnaire score in the standard care (control) group
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
Measured: Post-operative Month 3
Rate of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group
Qualitative
Measured: Month 3
Time spent connected to the Thess Monitoring device per patient in the experimental group
Quantitative, in minutes
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Dec 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single-center, randomized controlled trial (1:1 ratio) conducted as an open-label study comparing two management approaches: postoperative pain monitoring using the Thess Monitoring medical telemonitoring device in combination with the ANTALGEEK® protocol (experimental group) versus standard of care (control group).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680998
- Sponsor's protocol ID
- IDIL/2024/JL01
- Acronym
- TRACE
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.
PubMed 17284272Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
PubMed 22337572Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Atkins RM, Duckworth T, Kanis JA. Algodystrophy following Colles' fracture. J Hand Surg Br. 1989 May;14(2):161-4. doi: 10.1016/0266-7681_89_90118-6.
PubMed 2746114Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
PubMed 22019149Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Bonnet A, Lavand'homme P, France MN, Reding R, De Kock M. [Postoperative pain trajectories to identify risk of chronic postsurgical pain in living donors for liver transplantation]. Ann Fr Anesth Reanim. 2012 Dec;31(12):945-9. doi: 10.1016/j.annfar.2012.09.011. Epub 2012 Oct 30. French.
PubMed 23117039Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
PubMed 15733628Chapman CR, Donaldson G, Davis J, Ericson D, Billharz J. Postoperative pain patterns in chronic pain patients: a pilot study. Pain Med. 2009 Apr;10(3):481-7. doi: 10.1111/j.1526-4637.2008.00522.x. Epub 2008 Nov 5.
PubMed 18992044Chapman CR, Davis J, Donaldson GW, Naylor J, Winchester D. Postoperative pain trajectories in chronic pain patients undergoing surgery: the effects of chronic opioid pharmacotherapy on acute pain. J Pain. 2011 Dec;12(12):1240-6. doi: 10.1016/j.jpain.2011.07.005. Epub 2011 Oct 26.
PubMed 22036517Chaves JF, Brown JM. Spontaneous cognitive strategies for the control of clinical pain and stress. J Behav Med. 1987 Jun;10(3):263-76. doi: 10.1007/BF00846540.
PubMed 3612783Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847de Mos M, de Bruijn AG, Huygen FJ, Dieleman JP, Stricker BH, Sturkenboom MC. The incidence of complex regional pain syndrome: a population-based study. Pain. 2007 May;129(1-2):12-20. doi: 10.1016/j.pain.2006.09.008. Epub 2006 Nov 7.
PubMed 17084977Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
PubMed 32303379Duale C, Ouchchane L, Schoeffler P; EDONIS Investigating Group; Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.
PubMed 24373573
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery - A Single-Center, Randomized, Controlled Proof-of-Concept Study.
- ClinicalTrials.gov ID
- NCT07680998
- Acronym / sponsor ID
- TRACE / IDIL/2024/JL01
- Conditions
- Post Operative Pain, Chronic Pain
- Keywords
- Post Operative Pain, Pain Management, Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality. Poorly controlled APOP is a major risk factor for chronic postoperative pain. In France today, more and more patients undergo surgical procedures as outpatients. The challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either after outpatient surgery or after a prompt return home as part of an Enhanced Recovery After Surgery (ERAS) protocol. In outpatient surgery, postoperative pain management requires new strategies and/or organizational approaches to ensure high-quality pain management from the very start. The principle of analgesia for acute postoperative pain recommends: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy if maintenance therapy is insufficient, based on pain titration, using mild or strong oral opioids. Postoperative pain is the primary focus of postoperative care but the goal is also to improve postoperative recovery and enhance the patient's overall care. To date, there are no medical telemonitoring devices to support the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, enabling systematic postoperative screening for early and late warning signs of the risk of chronic pain. The Thess Monitoring device, which implements the ANTALGEEK® protocol, (TMA) was developed to optimize the efficiency of outpatient management of acute postoperative pain. It improves patients' adherence to maintenance treatment with adaptive, personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing). The aim is to ensure optimal pain resolution and improve early and late postoperative recovery during the first postoperative week. The TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain. By measuring pain scores daily during the first postoperative week, it identifies patients with a suboptimal pain trajectory who are at high risk of developing persistent pain beyond the third month. It also assesses warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3). Improving the patient care pathway via the TMA system should make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
Detailed description
The problem of acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year and potentially leading to numerous complications when inadequately managed. In the postoperative period, the implementation of effective analgesic therapy is a key factor in reducing early postoperative morbidity and mortality. Furthermore, poorly controlled PPS is one of the major risk factors for the development of chronic postoperative pain (CPOP). Optimizing analgesic medication to prevent an abnormal pain trajectory during the first postoperative week is a key strategy for preventing chronic postoperative pain.
Today, within the French healthcare system, an increasing number of patients undergo surgical procedures performed on an outpatient basis. The big challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either following outpatient surgery or after an early return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.
In outpatient surgery, improving postoperative pain management requires the implementation of new strategies and/or organizational approaches to ensure a high-quality pain management pathway from the very beginning.
The principle of analgesia for acute postoperative pain recommends a combination of: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy-if maintenance therapy is insufficient-based on the principle of pain titration, using oral opioids (mild or strong). While postoperative pain remains the primary focus of postoperative care, the goal is also to improve postoperative recovery more broadly and thereby enhance the patient's overall care.
The assessment of postoperative recovery in outpatient surgery patients using a medical telemonitoring device is associated with a reduction in discomfort caused by various postoperative symptoms, including postoperative pain. However, to date, there is no medical telemonitoring device that both supports the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, and enables systematic postoperative screening for early and late warning signs of the risk of chronic pain.
To this end, the Thess Monitoring medical telemonitoring device (which implements the ANTALGEEK® protocol) (TMA) was developed. It is a tool for continuous therapeutic support and postoperative telemonitoring designed to optimize the efficiency of outpatient management of acute postoperative pain in patients by improving adherence to maintenance therapy, adaptive and personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing), with the goal of ensuring optimal pain resolution and improved early and late postoperative recovery during the first postoperative week (Baseline-Day 7). To achieve this, the TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain: identify, through daily measurement of pain scores during the first postoperative week, patients with a suboptimal pain trajectory who are at high risk of developing persistent postoperative pain beyond the third month; assess warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3).
Improving the patient care pathway through the TMA system should thus make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
In this initial proof-of-concept study, the investigators aim to evaluate the performance and safety of the TMA medical device in the outpatient management of acute pain during the first postoperative week, as well as its impact on postoperative recovery and on reducing the risk of pain becoming chronic by the third postoperative month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, single-center, randomized controlled trial (1:1 ratio) conducted as an open-label study comparing two management approaches: postoperative pain monitoring using the Thess Monitoring medical telemonitoring device in combination with the ANTALGEEK® protocol (experimental group) versus standard of care (control group).
| Arm | Type | Receives |
|---|---|---|
| Postoperative pain management : standard care | No intervention | –Patients receiving standard postoperative analgesic care |
| Postoperative pain management using the Thess telemonitoring device | Experimental | Device: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocolPatients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients eligible for outpatient surgery.
- Patients undergoing surgery likely to result in moderate to severe pain.
- Patients available for a 3-month follow-up.
- Patients who have provided their free and informed consent.
- Patients who have signed the consent form.
Key exclusion criteria (6 listed)
- Patients participating in an interventional RIPH study involving a drug or classified as Category 1.
- Patients in an exclusion period determined by another study.
- Patients under judicial protection, guardianship, or conservatorship.
- Patients unable to express consent.
- Patient for whom it is impossible to provide informed information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocolThe Thess monitoring medical device (Thess Corp., Montpellier) uses the remote ANTALGEEK® telemonitoring protocol to manage pain in outpatients who have had surgery causing moderate-to-severe pain. It digitalizes and optimizes acute postoperative pain management at home by improving adherence to maintenance therapy, with adaptive, tailored control of analgesia through better use of opioid rescue therapy to reduce the adverse effects of opioid misuse and ensures optimal pain resolution and postoperative recovery during the first week. The ANTALGEEK decision-making algorithm and a medical telemonitoring protocol help patients follow their pain medication regimen, monitoring them in postoperative Week 1, based on the preoperative prescription, data on the patient's adherence to treatment, its efficacy and tolerability. | Device | Postoperative pain management using the Thess telemonitoring device |
Primary outcome
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group
Time frame: Day 2
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.
Time frame: Day 2
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
105 secondary outcomes
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Time frame: Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Time frame: Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Time frame: Day 7
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Time frame: Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Time frame: Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Time frame: Day 7
Pain progression in the experimental group
Time frame: Day 1
Pain progression in the experimental group
Time frame: Day 2
Pain progression in the experimental group
Time frame: Day 3
Pain progression in the experimental group
Time frame: Day 4
Pain progression in the experimental group
Time frame: Day 5
Pain progression in the experimental group
Time frame: Day 6
Pain progression in the experimental group
Time frame: Day 7
Pain progression in the experimental group
Time frame: Month 1
Pain progression in the experimental group
Time frame: Month 2
Pain progression in the experimental group
Time frame: Month 3
Pain progression in the in the standard care (control) group
Time frame: Day 1
Pain progression in the in the standard care (control) group
Time frame: Day 2
Pain progression in the in the standard care (control) group
Time frame: Day 3
Pain progression in the in the standard care (control) group
Time frame: Day 4
Pain progression in the in the standard care (control) group
Time frame: Day 5
Pain progression in the in the standard care (control) group
Time frame: Day 6
Pain progression in the in the standard care (control) group
Time frame: Day 7
Pain progression in the in the standard care (control) group
Time frame: Month 1
Pain progression in the in the standard care (control) group
Time frame: Month 2
Pain progression in the in the standard care (control) group
Time frame: Month 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Baseline
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Baseline
rate of adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group
Time frame: Day 1
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 2
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Day 2
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Day 3
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 4
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Day 4
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 5
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Day 5
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 6
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Time frame: Day 6
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 17284272Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.
- Background: PubMed 22337572Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 2746114Atkins RM, Duckworth T, Kanis JA. Algodystrophy following Colles' fracture. J Hand Surg Br. 1989 May;14(2):161-4. doi: 10.1016/0266-7681_89_90118-6.
- Background: PubMed 22019149Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 23117039Bonnet A, Lavand'homme P, France MN, Reding R, De Kock M. [Postoperative pain trajectories to identify risk of chronic postsurgical pain in living donors for liver transplantation]. Ann Fr Anesth Reanim. 2012 Dec;31(12):945-9. doi: 10.1016/j.annfar.2012.09.011. Epub 2012 Oct 30. French.
- Background: PubMed 15733628Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
- Background: PubMed 18992044Chapman CR, Donaldson G, Davis J, Ericson D, Billharz J. Postoperative pain patterns in chronic pain patients: a pilot study. Pain Med. 2009 Apr;10(3):481-7. doi: 10.1111/j.1526-4637.2008.00522.x. Epub 2008 Nov 5.
- Background: PubMed 22036517Chapman CR, Davis J, Donaldson GW, Naylor J, Winchester D. Postoperative pain trajectories in chronic pain patients undergoing surgery: the effects of chronic opioid pharmacotherapy on acute pain. J Pain. 2011 Dec;12(12):1240-6. doi: 10.1016/j.jpain.2011.07.005. Epub 2011 Oct 26.
- Background: PubMed 3612783Chaves JF, Brown JM. Spontaneous cognitive strategies for the control of clinical pain and stress. J Behav Med. 1987 Jun;10(3):263-76. doi: 10.1007/BF00846540.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol in people with Post Operative Pain and Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joël LHERMITE, Dr. (+334.66.68.30.50, joel.lhermite@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group (time frame: Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680998, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.