Anesthesia; Adverse EffectNCT05546021
Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries
A study testing NOL monitor in people with Anesthesia; Adverse Effect and Breast Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia. Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Breast Cancer
- What is being tested?
- NOL monitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection
Who cannot join
- Inability to give consent,
- atrial fibrillation,
- local anesthetic allergy,
- lumpectomy converted to Mastectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay
To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia.
Hypothesis:
- NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery.
- Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks.
- Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.
Read the detailed description
Optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. Despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. This may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. In that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. Recently, a nociception level monitor (NOL) based on an advanced software algorithm was developed using multiple physiological parameters. It offers an objective number (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. With the availability of NOL monitors, a meticulous adjustment in the administration of opioids became a possibility. Therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.
- Conditions
- Anesthesia; Adverse Effect, Breast Cancer
- Being tested
- NOL monitor
- Keywords
- nociception level monitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOL monitorProcedure or surgery
NOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to continuous monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's nociceptive state and analgesic effect, helping to optimize the administration of systemic and/or regional analgesics and avoiding overdose or underuse of these drugs.
The nociception level is a multiparameter monitor that combines information from the finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation, heart rate, heart rate variability, and their time derivatives into one index ranging from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation). The nociception level is a composite score derived from a set of physiologic variables (i.e., peripheral effectors of the autonomous nervous system): heart rate, heart rate variability, the amplitude of the photoplethysmogram, skin conductance, skin conductance variability, and the time derivatives of these variables.
| Study group | Role | What they receive |
|---|---|---|
| NOL monitor | Active comparator | Patients will receive opioids as per the guidance of a nociception level monitor (NOL) Receives: Procedure: NOL monitor |
| Standard care | No intervention | Patients will be treated as per the department´s standard protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroperative Remifentanil consumption
( peroperative, mg)
Measured: during the surgery
Peroperative Morphine consumption
(peroperative, mg)
Measured: during the surgery
Secondary outcomes (8)
Postoperative Maximum pain score
measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.
Measured: immediately after the surgery
Post-operative opioid consumption
Morphine, mg
Measured: immediately after the surgery
Eligible time to discharge
Time in the post anaesthesia care unit based on a post anaesthesia care score scheme derived from objective vital parameters (Minutes)
Measured: immediately after the surgery
Length of hospital stay
Hours
Measured: From admission to discharge, up to 72 hours
Incidence of post-operative nausea and vomiting
Number of patients with post-operative nausea and vomiting
Measured: immediately after the surgery
Requirement for additional antiemetic drugs
Number 1-3
Measured: immediately after the surgery
Persistent neuropathic pain after breast cancer surgery
Number of patients experiencing pain due to breast cancer surgery measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.
Measured: up to 3 months after surgery
Length of time in recovery room
minutes
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2023
- Primary completion31 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajesh Prabhakar Bhavsar, Principal investigator, University of Hospital of Southern Denmark - Aabenraa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546021
- Sponsor's protocol ID
- SHS-An-1-2022
- Status last verified
- Jul 2025
- First submitted
- 30 Aug 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
PubMed 27171828Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
PubMed 26154185Stockle PA, Julien M, Issa R, Decary E, Brulotte V, Drolet P, Henri M, Poirier M, Latulippe JF, Dorais M, Verdonck O, Fortier LP, Richebe P. Validation of the PMD100 and its NOL Index to detect nociception at different infusion regimen of remifentanil in patients under general anesthesia. Minerva Anestesiol. 2018 Oct;84(10):1160-1168. doi: 10.23736/S0375-9393.18.12720-9. Epub 2018 May 14.
PubMed 29756750Malachauskiene L, Bhavsar R, Bakke S, Keller J, Bhavsar S, Luy AM, Strom T. Influence of Nociception Level Monitor (NOL)-Guided Analgesic Delivery on Perioperative Course in Breast Surgeries: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Nov 22;60(12):1921. doi: 10.3390/medicina60121921.
PubMed 39768803
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay
- ClinicalTrials.gov ID
- NCT05546021
- Acronym / sponsor ID
- SHS-An-1-2022
- Conditions
- Anesthesia; Adverse Effect, Breast Cancer
- Keywords
- nociception level monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 19 Sep 2022 (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.
To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia.
Hypothesis:
- NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery.
- Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks.
- Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.
Detailed description
Optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. Despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. This may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. In that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. Recently, a nociception level monitor (NOL) based on an advanced software algorithm was developed using multiple physiological parameters. It offers an objective number (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. With the availability of NOL monitors, a meticulous adjustment in the administration of opioids became a possibility. Therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOL monitor | Active comparator | Procedure: NOL monitorPatients will receive opioids as per the guidance of a nociception level monitor (NOL) |
| Standard care | No intervention | –Patients will be treated as per the department´s standard protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection
Key exclusion criteria (4 listed)
- Inability to give consent,
- atrial fibrillation,
- local anesthetic allergy,
- lumpectomy converted to Mastectomy.
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 |
|---|---|---|
| NOL monitorNOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to continuous monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's nociceptive state and analgesic effect, helping to optimize the administration of systemic and/or regional analgesics and avoiding overdose or underuse of these drugs. The nociception level is a multiparameter monitor that combines information from the finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation, heart rate, heart rate variability, and their time derivatives into one index ranging from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation). The nociception level is a composite score derived from a set of physiologic variables (i.e., peripheral effectors of the autonomous nervous system): heart rate, heart rate variability, the amplitude of the photoplethysmogram, skin conductance, skin conductance variability, and the time derivatives of these variables. | Procedure or surgery | NOL monitor |
Primary outcome
Peroperative Remifentanil consumption
Time frame: during the surgery
( peroperative, mg)
Peroperative Morphine consumption
Time frame: during the surgery
(peroperative, mg)
8 secondary outcomes
Postoperative Maximum pain score
Time frame: immediately after the surgery
Post-operative opioid consumption
Time frame: immediately after the surgery
Eligible time to discharge
Time frame: immediately after the surgery
Length of hospital stay
Time frame: From admission to discharge, up to 72 hours
Incidence of post-operative nausea and vomiting
Time frame: immediately after the surgery
Requirement for additional antiemetic drugs
Time frame: immediately after the surgery
Persistent neuropathic pain after breast cancer surgery
Time frame: up to 3 months after surgery
Length of time in recovery room
Time frame: immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 27171828Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
- Background: PubMed 26154185Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
- Background: PubMed 29756750Stockle PA, Julien M, Issa R, Decary E, Brulotte V, Drolet P, Henri M, Poirier M, Latulippe JF, Dorais M, Verdonck O, Fortier LP, Richebe P. Validation of the PMD100 and its NOL Index to detect nociception at different infusion regimen of remifentanil in patients under general anesthesia. Minerva Anestesiol. 2018 Oct;84(10):1160-1168. doi: 10.23736/S0375-9393.18.12720-9. Epub 2018 May 14.
- Background: PubMed 39768803Malachauskiene L, Bhavsar R, Bakke S, Keller J, Bhavsar S, Luy AM, Strom T. Influence of Nociception Level Monitor (NOL)-Guided Analgesic Delivery on Perioperative Course in Breast Surgeries: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Nov 22;60(12):1921. doi: 10.3390/medicina60121921.
- Individual participant dataSharing planned: No
Related trials for Anesthesia; Adverse Effect
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Active, not recruiting
Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees
Surgical Procedures, Noise
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
Enrolling by invitationPhase 1/2
This Study Aims to Determine Whether Lower Doses (4 µg) of Intrathecal Dexmedetomidine Can Provide Comparable Analgesic Benefits While Minimizing Adverse Hemodynamic Effects in Patients Encountered in Our Setup( Shifa International Hospital Islamabad).
Intrathecal Dexmedetomidine
RecruitingObservational study
Paramedian Incidence Angles in Spinal Anaesthesia
Anesthesia; Adverse Effect, Spinal and Epidural
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. This study is not recruiting at the moment.
Rajesh Prabhakar Bhavsar principal investigator
University of Hospital of Southern Denmark - Aabenraa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOL monitor in people with Anesthesia; Adverse Effect and Breast Cancer, run by University of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peroperative Remifentanil consumption (time frame: during the surgery). 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 NCT05546021, which also lists 4 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 31 Jul 2025.