- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07638514
Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery (CATHORNOT)
A Comparative Evaluation of Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery
Postoperative pain following hindfoot surgery is often severe and can persist for several days. It frequently leads to the use of systemic analgesics, particularly opioids, whose adverse effects are well known. Furthermore, poorly controlled postoperative pain is a recognized independent risk factor for the development of chronic pain.
Ambulatory perineural catheter techniques, already used in our department for hindfoot surgeries, allow for continuous infusion of local anesthetic. They have demonstrated their efficacy in numerous orthopedic surgeries, but data specific to hindfoot surgery remain limited. It therefore seems appropriate to evaluate whether prolonged analgesia via a perineural catheter improves postoperative pain management and promotes functional recovery.
The study is conducted as a practice evaluation audit. It relies on the collection of data from routine care, without any modification to intraoperative care. This methodology allows for an objective evaluation of the benefits of the perineural catheter compared to a single-injection popliteal sciatic block with local anesthetic, while documenting the frequency and nature of complications associated with the technique (leaks, accidental or intentional catheter removal).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Benjamin DUMARTINET
- Phone Number: +33 241353637
- Email: benjamin.dumartinet@chu-angers.fr
Study Locations
-
-
-
Angers, France
- University Hospital of Angers
-
Contact:
- Benjamin DUMARTINET
- Phone Number: +33 241353637
- Email: benjamin.dumartinet@chu-angers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients;
- Patients with an American Society of Anesthesiologists physical status (ASA score) of 1, 2, or 3;
- Patients who have undergone hindfoot surgery;
- Patients capable of completing the questionnaires.
Exclusion Criteria:
- Contraindications to regional anesthesia (known hypersensitivity to the local anesthetic, infection at the injection site, uncontrolled neurological condition);
- Emergency surgery
- Cognitive impairment;
- Uncontrolled psychiatric condition;
- Pregnancy or breastfeeding;
- Substance abuse;
- Use of neuroleptics or lithium;
- Individuals subject to legal guardianship
- Individuals deprived of liberty by judicial or administrative order
- Patients who object to the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
regional anesthesia
|
All patients are contacted by phone to assess pain during movement and at rest on each of the first 3 days after surgery, as well as their use of various pain medications
|
|
ambulatory perineural catheter
|
All patients are contacted by phone to assess pain during movement and at rest on each of the first 3 days after surgery, as well as their use of various pain medications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain on movement using a numerical scale from 0 to 11
Time Frame: Day 1 postoperative
|
to compare the efficacy of an ambulatory perineural catheter for prolonging analgesia and reducing postoperative pain following hindfoot surgery, compared with single-shot regional anesthesia
|
Day 1 postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain at rest using a numerical scale from 0 to 11
Time Frame: From Baseline to Day 3
|
to assess analgesic efficacy at rest
|
From Baseline to Day 3
|
|
postoperative pain during mobilization using a numerical scale from 0 to 11
Time Frame: From Baseline to Day 3
|
to evaluate the analgesic efficacy during mobilization
|
From Baseline to Day 3
|
|
Postoperative consumption of morphine equivalents in milligrams
Time Frame: From Baseline to Day 3
|
Cumulative
|
From Baseline to Day 3
|
|
Daily postoperative consumption of morphine equivalents in milligrams
Time Frame: Baseline, Day 1, Day 2 and Day 3
|
Daily
|
Baseline, Day 1, Day 2 and Day 3
|
|
Postoperative use of non-opioid analgesics
Time Frame: From Baseline to Day 3
|
Cumulative
|
From Baseline to Day 3
|
|
Daily postoperative use of non-opioid analgesics
Time Frame: Baseline, Day 1, Day 2 and Day 3
|
Daily
|
Baseline, Day 1, Day 2 and Day 3
|
|
French Quality of Recovery -15 score (FQoR-15 - from 0 to 150)
Time Frame: Baseline and day 2
|
to assess functional recovery and postoperative rehabilitation
|
Baseline and day 2
|
|
number of complications
Time Frame: From baseline to day 3
|
Accidental or intentional removal of the catheter Leaks at the injection site or in the infusion system Bruise or local infection Crashes potentially related to the residual engine block
|
From baseline to day 3
|
|
proportion of patients experiencing at least one postoperative complication following hindfoot surgery
Time Frame: From baseline to Day 3
|
Readmission to the hospital Consultation with the attending physician for uncontrolled postoperative pain or complications related to the procedure Confirmed infection with antibiotic treatment initiated
|
From baseline to Day 3
|
|
length of hospital stay, calculated in whole days
Time Frame: From Baseline to Day 3
|
Duration censored on Day 3 if the patient is still hospitalized on that date
|
From Baseline to Day 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin DUMARTINET, University Hospital of Angers
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC26_0116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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