Меню
Набор скоро начнётся NCT07638514

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

— Наблюдательное Hindfoot Surgery Analgesia Perineural Catheter

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Phone contact, perineural catheter, Regional Anesthesia.
Кому может быть актуально
Состояния в реестре: Hindfoot Surgery, Analgesia, Perineural Catheter. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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).

Вмешательства

  • Другое 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
  • Устройство perineural catheter
    Use of a perineural catheter for ambulatory analgesia
  • Процедура Regional Anesthesia
    regional anesthesia

Первичные конечные точки

  • Pain on movement using a numerical scale from 0 (no pain) to 11 (maximum pain) [Срок оценки: Day 1 postoperative]
Вторичные конечные точки (10)
  • postoperative pain at rest using a numerical scale from 0 (no pain) to 11 (maximum pain) [Срок оценки: From Baseline to Day 3]
  • postoperative pain during mobilization using a numerical scale from 0 (no pain) to 11 (maximum pain) [Срок оценки: From Baseline to Day 3]
  • Postoperative consumption of morphine equivalents in milligrams [Срок оценки: From Baseline to Day 3]
  • Daily postoperative consumption of morphine equivalents in milligrams [Срок оценки: Baseline, Day 1, Day 2 and Day 3]
  • Postoperative use of non-opioid analgesics [Срок оценки: From Baseline to Day 3]
  • Daily postoperative use of non-opioid analgesics [Срок оценки: Baseline, Day 1, Day 2 and Day 3]
  • French Quality of Recovery -15 score (FQoR-15 - from 0 to 150) [Срок оценки: Baseline and day 2]
  • number of complications [Срок оценки: From baseline to day 3]
  • proportion of patients experiencing at least one postoperative complication following hindfoot surgery [Срок оценки: From baseline to Day 3]
  • length of hospital stay, calculated in whole days [Срок оценки: From Baseline to Day 3]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • University Hospital of Angers — Angers

Идентификаторы

NCT: NCT07638514 · 49RC26_0116

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗