Effect of Infraclavicular Nerve Block Versus General Anaesthesia for Acute Postoperative Pain After Distal Radial Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Acute postoperative pain score
研究概览
简要总结
This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.
详细描述
A single blinded randomized control trial will be performed to compare regional anaesthesia with single shot infraclavicular nerve block versus general anaesthesia.
The primary outcome was postoperative NRS pain score (0-10) with movement at 24 hours after surgery. No suitable references for postoperative NRS pain scores at 24 hours that could be used for sample size calculation was found. Based on a previous study on RA versus GA for hand surgery, the standard deviation estimate of the treatments for sample size calculation was 2.86. To detect a difference in NRS pain score of 2.4/10 at a significance level of 0.05 and a power of 0.80, the minimum number of patients required per group was 23. A difference of 2.4 in NRS pain score was chosen because this has been shown to correspond to 'much improvement' in pain relief, which is clinically significant. To take into account for possible dropouts, 26 patients were recruited into each group.
Patients will be approached in the general ward before operation. The aims of the study and need for follow up assessment would be explained and patient will be recruited only if s/he agrees. After agreeing to join the study, patients will be randomly allocated to one of two groups: 1) General anaesthesia (GA) 2) Regional Anaesthesia with infraclavicular block (RA). Outcomes of patients in receiving general anaesthesia (GA) will be compared with patients receiving infraclavicular nerve block (RA).
Data Analysis Intention-to-treat will be used. Patients will remain in their initial designated groups for data analysis even if there is a change in surgical or anaesthetic/analgesic management, as long as they are undergoing distal radial fracture surgery not involving another operative site (eg bone graft). Patients in the RA group who required conversion to general anaesthesia due to inadequate infraclavicular block would remain in the RA group for data analysis.
Statistical methods used:
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
- Single (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
- •ASA I-III
- •Age 18-80 years old
- •Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)
排除标准
- •Surgery involving more than distal radial fracture of the affected arm
- •Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
- •History of chronic pain
- •Alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
- •Patients with liver dysfunction (Plasma bilirubin over 34 mol/L, INR >/=1.7, ALT and AST over 100U/L)
- •Pre-existing neurological or muscular disorders
- •Psychiatric illness
- •Impaired or retarded mental state
- •Not self-ambulatory before operation
- •Pregnancy
- •Local infection
- •Patient refusal
研究组 & 干预措施
General Anaesthesia
Patients would receive routine general anaesthesia for their distal radial fracture surgery
干预措施: General anaesthesia (Procedure)
Regional Anaesthesia
Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery
干预措施: Infraclavicular nerve block (Procedure)
结局指标
主要结局
Acute postoperative pain score
时间窗: At postoperative day 1
pain score would be recorded on postoperative day 1 using numeral rating scale
次要结局
- Chronic pain score(At postoperative 3rd month)
- Analgesic drug consumption(On discharge day)
研究者
Wong Sau Ching Stanley
Clinical Assistant Professor
The University of Hong Kong