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

5. juni 2026 opdateret af: University Hospital, Angers

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

University Hospital of Angers

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
regional anæstesi
Andet: 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
ambulatory perineural catheter
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain on movement using a numerical scale from 0 to 11
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
postoperative pain at rest using a numerical scale from 0 to 11
Tidsramme: 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
Tidsramme: From Baseline to Day 3
to evaluate the analgesic efficacy during mobilization
From Baseline to Day 3
Postoperative consumption of morphine equivalents in milligrams
Tidsramme: From Baseline to Day 3
Cumulative
From Baseline to Day 3
Daily postoperative consumption of morphine equivalents in milligrams
Tidsramme: Baseline, Day 1, Day 2 and Day 3
Daily
Baseline, Day 1, Day 2 and Day 3
Postoperative use of non-opioid analgesics
Tidsramme: From Baseline to Day 3
Cumulative
From Baseline to Day 3
Daily postoperative use of non-opioid analgesics
Tidsramme: 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)
Tidsramme: Baseline and day 2
to assess functional recovery and postoperative rehabilitation
Baseline and day 2
number of complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Baseline to Day 3
Duration censored on Day 3 if the patient is still hospitalized on that date
From Baseline to Day 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Angers

Efterforskere

  • Ledende efterforsker: Benjamin DUMARTINET, University Hospital of Angers

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

7. februar 2027

Studieafslutning (Anslået)

7. februar 2027

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 49RC26_0116

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