Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Post operative pain score
研究概览
简要总结
This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.
详细描述
A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.
Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic cholecystectomy
- •ASA I, II or III
排除标准
- •Patients that don't consent to be included
- •Allergy to levobupivacaine
研究组 & 干预措施
LaGRA
regional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal
干预措施: Levobupivacaine (Drug)
Placebo
Sham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal
干预措施: Placebo (Drug)
结局指标
主要结局
Post operative pain score
时间窗: 6 hours post operatively
Visual analogue pain scores ranging from 0 to 10
次要结局
- Daycase rates(Day of surgery)
- Analgesic use(Perioperative period including first 6 hours post operatively)
- Opioid use(Perioperative period including first 6 hours post operatively)
- Readmission rate(30 days post operative)
研究者
Des Toomey
Consultant Surgeon
Health Service Executive, Ireland