A Comparative Evaluation of Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
regional anesthesia
干预措施: Regional Anesthesia (Procedure)
ambulatory perineural catheter
干预措施: perineural catheter (Device)
regional anesthesia
干预措施: Phone contact (Other)
ambulatory perineural catheter
干预措施: Phone contact (Other)
结局指标
主要结局
Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain)
时间窗: 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)
次要结局
- French Quality of Recovery -15 score (FQoR-15 - from 0 to 150)(Postoperative Day 0 through Postoperative Day 2)
- postoperative pain at rest using a numerical scale from 0 (no pain) to 10 (maximum pain)(Postoperative Day 0 through Postoperative Day 3)
- postoperative pain during mobilization using a numerical scale from 0 (no pain) to 10 (maximum pain)(From Baseline to Day 3)
- Postoperative consumption of morphine equivalents in milligrams(Postoperative Day 0 through Postoperative Day 3)
- Postoperative use of non-opioid analgesics(Postoperative Day 0 through Postoperative Day 3)
- Proportion of patients experiencing at least one adverse event related to the regional anesthesia technique(Postoperative Day 0 through Postoperative Day 3)
- proportion of patients experiencing at least one postoperative complication following hindfoot surgery(Postoperative Day 0 through Postoperative Day 3)
- length of hospital stay, calculated in whole days(Postoperative Day 0 through Postoperative Day 3)
- Daily postoperative consumption of morphine equivalents in milligrams(Baseline, Day 1, Day 2 and Day 3)
- Daily postoperative use of non-opioid analgesics(Baseline, Day 1, Day 2 and Day 3)