NCT07638514

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain on movement using a numerical scale from 0 to 11

    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 Outcomes (10)

  • postoperative pain at rest using a numerical scale from 0 to 11

    From Baseline to Day 3

  • postoperative pain during mobilization using a numerical scale from 0 to 11

    From Baseline to Day 3

  • Postoperative consumption of morphine equivalents in milligrams

    From Baseline to Day 3

  • Daily postoperative consumption of morphine equivalents in milligrams

    Baseline, Day 1, Day 2 and Day 3

  • Postoperative use of non-opioid analgesics

    From Baseline to Day 3

  • +5 more secondary outcomes

Study Arms (2)

regional anesthesia

Other: Phone contact

ambulatory perineural catheter

Other: Phone contact

Interventions

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 catheterregional anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University Hospital of Angers

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Angers

Angers, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin DUMARTINET

    University Hospital of Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 7, 2027

Study Completion (Estimated)

February 7, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations