Orthopaedic SurgeryR-CAPENCT02720965
Remote Controlled Analgesia on Patient Experience
A study of Orthopaedic Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopaedic Surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2016to 2 Dec 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18 or more, up to 80 years;
- Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
- Eligible to outpatient care;
- Respecting the ambivalence clause defined below:
- no cons-indication to analgesic perineural catheter;
- not known allergy to local anesthetics;
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- likely to be a candidate for continuous nerve block analgesia;
- Ability to complete a self-reported questionnaire;
- Have given written informed consent
Who cannot join
- Age less than 18 or more than 80 years;
- Pregnant or nursing women ;
- Not being affiliated to the social security scheme;
- Known allergy to local anesthetics of the amide type;
- Regulatory constraints in the outpatient management of perineural catheters not respected:
- Inability of daily nursing care;
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- No presence of a responsible adult at home the night of the intervention;
- Scheduled hospital stay;
- ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
- Spontaneous request for continuous nerve block or single injection;
- Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Topic treated with antipsychotics (neuroleptics or lithium);
- Subject has a documented chronic pain syndrome;
- Active consumer of narcotic topic;
- Topic have not signed informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology and critical care, Lapeyronie University Hospital
Montpellier, 34295
About this study
Official title: Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
Read more
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
Read the detailed description
Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.
Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
- Conditions
- Orthopaedic Surgery
- Being tested
- Remote-controlled perineural local anesthetics delivery
- Keywords
- Pain Acute, Orthopedic Surgery, Satisfaction Nerve Blocks
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote-controlled perineural local anesthetics deliveryOther
Remote-controlled perineural local anesthetics delivery
| Study group | Role | What they receive |
|---|---|---|
| Electronic pump | Experimental | Continuous nerve blocks Remote-controlled perineural local anesthetics delivery Receives: Other: Remote-controlled perineural local anesthetics delivery |
| single injection | No intervention | single injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience and satisfaction scale (EVAN-G)
Description: Patient experience and satisfaction scale
Measured: Second day after surgery
Secondary outcomes (1)
Patient quality of recovery (QoR)
Description: Patient quality of recovery
Measured: First day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start7 Jun 2016
- Primary completion21 Oct 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopaedic SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier CAPDEVILA, M.D., Ph.D., Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720965
- Sponsor's protocol ID
- 9677
- Acronym
- R-CAPE
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Maurice-Szamburski A, Grillo P, Cuvillon P, Gazeau T, Delaunay L, Auquier P, Bringuier S, Capdevila X. Comparison of continuous with single-injection regional analgesia on patient experience after ambulatory orthopaedic surgery: a randomised multicentre trial. Br J Anaesth. 2022 Sep;129(3):435-444. doi: 10.1016/j.bja.2022.05.039. Epub 2022 Jul 7.
PubMed 35811140
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02720965
- Acronym / sponsor ID
- R-CAPE / 9677
- Conditions
- Orthopaedic Surgery
- Keywords
- Pain Acute, Orthopedic Surgery, Satisfaction Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 28 Mar 2016 (estimated)
- 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.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
Detailed description
Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.
Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic pump | Experimental | Other: Remote-controlled perineural local anesthetics deliveryContinuous nerve blocks Remote-controlled perineural local anesthetics delivery |
| single injection | No intervention | –single injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject aged 18 or more, up to 80 years;
- Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
- Eligible to outpatient care;
- Respecting the ambivalence clause defined below:
- Ability to complete a self-reported questionnaire;
Key exclusion criteria (16 listed)
- Age less than 18 or more than 80 years;
- Pregnant or nursing women ;
- Not being affiliated to the social security scheme;
- Known allergy to local anesthetics of the amide type;
- Regulatory constraints in the outpatient management of perineural catheters not respected:
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 |
|---|---|---|
| Remote-controlled perineural local anesthetics deliveryRemote-controlled perineural local anesthetics delivery | Other | Electronic pump |
Primary outcome
Patient experience and satisfaction scale (EVAN-G)
Time frame: Second day after surgery
Description: Patient experience and satisfaction scale
1 secondary outcome
Patient quality of recovery (QoR)
Time frame: First day 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 3 Apr 2020.
- Derived from this study: PubMed 35811140Maurice-Szamburski A, Grillo P, Cuvillon P, Gazeau T, Delaunay L, Auquier P, Bringuier S, Capdevila X. Comparison of continuous with single-injection regional analgesia on patient experience after ambulatory orthopaedic surgery: a randomised multicentre trial. Br J Anaesth. 2022 Sep;129(3):435-444. doi: 10.1016/j.bja.2022.05.039. Epub 2022 Jul 7.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xavier CAPDEVILA, M.D., Ph.D. study chair
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Orthopaedic Surgery, run by University Hospital, Montpellier 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 9 inclusion and 16 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 3 Apr 2020. 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?
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?
Patient experience and satisfaction scale (EVAN-G) (time frame: Second day after surgery). 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 NCT02720965, which also lists 1 linked publication.
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 3 Apr 2020.