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Not yet recruiting NCT07638514

Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery

— Observational Hindfoot Surgery Analgesia Perineural Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phone contact, perineural catheter, Regional Anesthesia.
Who it may be relevant to
Registry conditions: Hindfoot Surgery, Analgesia, Perineural Catheter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Comparative Evaluation of Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery

Overview

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).

Interventions

  • Other Phone contact
    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
  • Device perineural catheter
    Use of a perineural catheter for ambulatory analgesia
  • Procedure Regional Anesthesia
    regional anesthesia

Primary outcome measures

  • Pain on movement using a numerical scale from 0 (no pain) to 11 (maximum pain) [Time frame: Day 1 postoperative]
Secondary outcome measures (10)
  • postoperative pain at rest using a numerical scale from 0 (no pain) to 11 (maximum pain) [Time frame: From Baseline to Day 3]
  • postoperative pain during mobilization using a numerical scale from 0 (no pain) to 11 (maximum pain) [Time frame: From Baseline to Day 3]
  • Postoperative consumption of morphine equivalents in milligrams [Time frame: From Baseline to Day 3]
  • Daily postoperative consumption of morphine equivalents in milligrams [Time frame: Baseline, Day 1, Day 2 and Day 3]
  • Postoperative use of non-opioid analgesics [Time frame: From Baseline to Day 3]
  • Daily postoperative use of non-opioid analgesics [Time frame: 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]
  • number of complications [Time frame: From baseline to day 3]
  • proportion of patients experiencing at least one postoperative complication following hindfoot surgery [Time frame: From baseline to Day 3]
  • length of hospital stay, calculated in whole days [Time frame: From Baseline to Day 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital of Angers — Angers

Identifiers

NCT: NCT07638514 · 49RC26_0116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗