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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Benjamin DUMARTINET
- Número de telefone: +33 241353637
- E-mail: benjamin.dumartinet@chu-angers.fr
Locais de estudo
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Angers, França
- University Hospital of Angers
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Contato:
- Benjamin DUMARTINET
- Número de telefone: +33 241353637
- E-mail: benjamin.dumartinet@chu-angers.fr
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
anestesia regional
|
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
regional anesthesia
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ambulatory perineural catheter
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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
Use of a perineural catheter for ambulatory analgesia
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain)
Prazo: Day 1 postoperative
|
Postoperative pain on movement at Day 1. Pain intensity during movement assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst possible pain)
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Day 1 postoperative
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Daily postoperative consumption of morphine equivalents in milligrams
Prazo: Baseline, Day 1, Day 2 and Day 3
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Daily
|
Baseline, Day 1, Day 2 and Day 3
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|
Daily postoperative use of non-opioid analgesics
Prazo: Baseline, Day 1, Day 2 and Day 3
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Daily
|
Baseline, Day 1, Day 2 and Day 3
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postoperative pain at rest using a numerical scale from 0 (no pain) to 10 (maximum pain)
Prazo: Postoperative Day 0 through Postoperative Day 3
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to assess analgesic efficacy at rest
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Postoperative Day 0 through Postoperative Day 3
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|
postoperative pain during mobilization using a numerical scale from 0 (no pain) to 10 (maximum pain)
Prazo: From Baseline to Day 3
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to evaluate the analgesic efficacy during mobilization
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From Baseline to Day 3
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|
Postoperative consumption of morphine equivalents in milligrams
Prazo: Postoperative Day 0 through Postoperative Day 3
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Cumulative
|
Postoperative Day 0 through Postoperative Day 3
|
|
Postoperative use of non-opioid analgesics
Prazo: Postoperative Day 0 through Postoperative Day 3
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Cumulative
|
Postoperative Day 0 through Postoperative Day 3
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|
French Quality of Recovery -15 score (FQoR-15 - from 0 to 150)
Prazo: Postoperative Day 0 through Postoperative Day 2
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to assess functional recovery and postoperative rehabilitation
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Postoperative Day 0 through Postoperative Day 2
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|
Proportion of patients experiencing at least one adverse event related to the regional anesthesia technique
Prazo: Postoperative Day 0 through Postoperative Day 3
|
Accidental or intentional removal of the catheter Leaks at the injection site or in the infusion system Bruise or local infection Falls potentially related to the residual motor block
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Postoperative Day 0 through Postoperative Day 3
|
|
proportion of patients experiencing at least one postoperative complication following hindfoot surgery
Prazo: Postoperative Day 0 through Postoperative Day 3
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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
|
Postoperative Day 0 through Postoperative Day 3
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|
length of hospital stay, calculated in whole days
Prazo: Postoperative Day 0 through Postoperative Day 3
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Duration censored on Day 3 if the patient is still hospitalized on that date
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Postoperative Day 0 through Postoperative Day 3
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Benjamin DUMARTINET, University Hospital of Angers
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 49RC26_0116
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