Extension of the Analgesia of an Interscalene Block of the Brachial Plexus by Combined Injection of Dexamethasone and Dexmedetomidine, After Arthroscopic Shoulder Surgery: Randomized, Controlled, Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Effectiveness of dexmedetomidine in prolonging analgesia
研究概览
简要总结
The main objective of the study is to demonstrate the efficacy of Dexmedetomidine on the prolongation of analgesia obtained by interscalenic bloc of the brachial plexus and intravenous injection of Dexamethasone (efficacy objective).
详细描述
This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of Dexmedetomidine over the absence of Dexmedetomidine, in adjuvantation of a loco regional anesthesia (interscalenic bloc of the brachial plexus + intravenous injection of Dexamethasone), on the prolongation of the analgesia, following a surgery of the rotator cuff of the shoulder under arthroscopy.
Patients will be randomized into 2 groups according to the treatment received:
- Dexmedetomidine;
- Nothing (control arm). The investigator (anesthesiologist) who will perform the randomization will not be blinded to the treatment.
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
- Double (Participant, Outcomes Assessor)
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;
- •Patient undergoing arthroscopic shoulder surgery to repair the rotator cuff tendons;
- •Patient capable of understanding the information related to the study, of reading the information leaflet and agreeing to sign the consent form.
排除标准
- •Patient on oral morphines before surgery;
- •Contraindication to performing a general anesthesia associated with a shoulder loco regional anesthesia in a single injection;
- •Contraindication to take oral morphines;
- •Any non-arthroscopic repair (intraoperative conversion to "open sky" technique);
- •Any other loco regional anesthesia than an interscalenic block (change of intraoperative strategy);
- •Pregnant or lactating woman;
- •Intolerance or allergy or contraindication to one of the treatments under study;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial.
研究组 & 干预措施
DMD
Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
干预措施: Dexmedetomidine (Drug)
DMD
Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
干预措施: Ropivacaine (Drug)
DMD
Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
干预措施: Dexamethasone (Drug)
Control
Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection
干预措施: Ropivacaine (Drug)
Control
Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Effectiveness of dexmedetomidine in prolonging analgesia
时间窗: 96 hours
Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake.
次要结局
- Duration of the sensitive block(96 hours)
- Numerical scale from 0 to 10(48 hours)
- Safety analysis(96 hours)
- Oral opioid analgesics(48 hours)
- Duration of the motor block(96 hours)
- 4-level Likert scale(96 hours)