Effect of patient controlled continuous infraclavicular block on early functional rehabilitation following surgeries for fractures around the elbow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mayo Elbow Performance Score
研究概览
简要总结
Thisprospective, randomised clinical trial will be conducted in the department ofAnaesthesia and Intensive Care, PGIMER, Chandigarh with the aim ofinvestigating the effect of analgesia via patient controlled continuousinfraclavicular brachial plexus block technique, on early functionalrehabilitation after surgery for fractures around elbow. Patients will be allocated to one of the two groups of 20 patients each: Group Ipatients (n=20) will receive intravenous PCA in the postoperative period, usingpatient controlled bolus of 1mg Morphine intravenously with a lockout intervalof 15 minutes.Group IIpatients (n=20) will receive continuousinfraclavicular brachial plexus block using 0.2% Ropivacaine at a basal rate of5 ml / hr, with a patient controlled bolus of 3ml and a lockout interval of 30minutes. All patients will be assessed after3 weeks and 3 months following discharge. MEPS score will be assessed duringthese sessions by an assessor who is blinded to the group allocations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients scheduled to undergo open reduction, internal fixation surgery for fractures around the elbow, under general anaesthesia will be enrolled in the study.
排除标准
- •â–Local infection at the block site â–Brachial plexus injury â–Coagulopathy â–Sepsis â–Obesity (BMI>30) â–Allergy to local anesthetics / opioids â–Uncontrolled hypertension or ischemic heart disease â–Renal or hepatic dysfunction â–Bronchopulmonary disorders â–Pre-existing neurological deficit â–Prior surgery in the infraclavicular area â–Psychiatric illness â–Inability to cooperate or understand the study protocol.
- •â–Patients who fail to understand the scoring systems used in the study â–Refusal to give consent for the study.
结局指标
主要结局
Mayo Elbow Performance Score
时间窗: 3 weeks following discharge
次要结局
- 1.Mayo Elbow Performance Score at 3 months following discharge from the hospital(2. Numeric rating scale (NRS) score 4 hourly for 72 hours)