Assessment of Recovery After Adductor Canal Block Analgesia Associated Either With Infiltration Between Popliteal Artery and Posterior Capsule, or With Surgical Peri-articular Infiltration for Patients Treated by Improved Recovery Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Post-operative recovery from knee prosthesis surgery
研究概览
简要总结
The purpose of the study is post-operative recovery from prosthetic knee surgery will be assessed by the proportion of patients entering the Accelerated Rehabilitation After Surgery program eligible for discharge from hospital at 2 days according to the following definition: Chung score ≥ 9 with no intravenous (IV) infusion, solid food, transit restored, no signs of infection and Cumulated Ambulation Score D1 ≥ 5 (if discharged on Day 1), Cumulated Ambulation Score Day 2 ≥ 10 (if discharged on Day 2), or Cumulated Ambulation Score Day 3 ≥ 11/18.
详细描述
This is a monocentric, interventional, prospective, comparative, randomized study in 2 parallel groups, single-blind. The study is proposed to the patient during the preoperative anesthetic consultation. The patient and the people carrying out the functional assessments (physiotherapists) will be blinded to the analgesia received, unlike the investigator.
Patients will be included by an anesthesiologist during the preoperative anesthetic consultation. After the Accelerated Rehabilitation After Surgery consultation, they will then be operated on (Day 0) and seen up to 5 times post-operatively over a period of 45 days for the purposes of the study: at 24h, 48h, 72h, discharge from hospital and 45 days post operative. Discharge from hospital occurs during follow-up depending on the patient's condition. These visits will coincide with follow-up consultations with the surgeon as part of the usual management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient and the people carrying out the functional assessments (physiotherapists) will be blinded to the analgesia received, unlike the investigator.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a score "American Society of Anesthesiologists" I to III;
- •Patient undergoing initial unilateral prosthetic knee replacement surgery for osteoarthritis;
- •Patient eligible for analgesia by block of the adductor canal associated with additional infiltration;
- •Patient accepting to follow the enhanced recovery program after surgery;
- •Patient who signed an informed consent form to participate in the study.
排除标准
- •Patient with a known allergy to a study product;
- •Patient having undergone previous surgery with a prosthesis on the knee to be operated on;
- •Patient with morbid obesity (Body Mass Index > 40);
- •Patient with a pre-existing inability to walk;
- •Patient with a history of chronic neuropathic pain in the leg undergoing surgery;
- •Patient with heart failure with impaired ejection fraction;
- •Patient with a history of drug addiction;
- •Patient chronically taking level III analgesics;
- •Patient taking gabapentin or pregabalin chronically;
- •Patient with severe renal or hepatic impairment;
- •Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group;
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
- •Pregnant or likely to be pregnant (of childbearing age without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Post-operative recovery from knee prosthesis surgery
时间窗: 3 days
Post-operative recovery from prosthetic knee surgery will be assessed by the proportion of patients entering the Accelerated Rehabilitation After Surgery program eligible for discharge from hospital at 2 days according to the following definition: Chung score ≥ 9 with no intravenous (IV) infusion, solid food, transit restored, no signs of infection and Cumulated Ambulation Score D1 ≥ 5 (if discharged on Day 1), Cumulated Ambulation Score Day 2 ≥ 10 (if discharged on Day 2), or Cumulated Ambulation Score Day 3 ≥ 11/18.
次要结局
未报告次要终点