Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- length of stay in the Post-Interventional Monitoring Room
研究概览
简要总结
The purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local anesthesia).
详细描述
This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery.
The study population is composed of adult patients with complete or partial rotator cuff tears requiring reconstructive surgery under anesthesia at Hôpital Privé Clairval or Clinique Monticelli-Vélodrome.
Patients will be seen three times: at inclusion (during the preoperative consultation with the anesthetist), on the day of surgery (hospitalization), and at the follow-up visit (during the postoperative consultation with the surgeon). They will also be contacted by telephone on D1, D3 and D15 to optimize their follow-up. The duration of each patient's participation is approximately one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open-label study
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
- •Age ≥ 18 years;
- •Patients with surgically repairable complete or partial rotator cuff tears;
- •American Society of Anesthesiologists Class I to III;
- •Patient able to understand study information;
- •Patient willing to accept study evaluations and follow-up visits;
- •Affiliation with a social insurance plan;
- •Patient having been informed and having agreed to participate in the study by signing an informed consent form.
排除标准
- •Contraindication to general or locoregional anesthesia;
- •Chronic opioid use;
- •Patient unable to understand study information (linguistic, psychological, cognitive, etc.);
- •Patient unable to answer a self-questionnaire;
- •Patient participating in or being excluded from another interventional research study;
- •Pregnant or breast-feeding women;
- •Protected patient (under legal protection, guardianship or deprived of liberty by judicial or administrative decision).
研究组 & 干预措施
Locoregional anesthesia
patients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus.
干预措施: arthroscopy of the shoulder rotator cuff (Procedure)
Locoregional anesthesia + general anesthesia
patients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus.
干预措施: arthroscopy of the shoulder rotator cuff (Procedure)
结局指标
主要结局
length of stay in the Post-Interventional Monitoring Room
时间窗: Day 0
The primary endpoint is the length of stay in the Post-Interventional Monitoring Room from discharge from the operating room to an Aldrete score \> 8 leading to discharge from the Post-Interventional Monitoring Room.
次要结局
未报告次要终点