Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- VAS pain score
研究概览
简要总结
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.
Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Elective laparoscopic cholecystectomy
- •18 years old or over
排除标准
- •Emergency surgery
- •Under 18 year olds
研究组 & 干预措施
Control
Sham wash, sham injection
干预措施: 0.9% normal saline solution (Drug)
Subperitoneal injection
Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder
干预措施: Bupivocaine (Drug)
Topical LA
Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm
干预措施: Bupivocaine (Drug)
结局指标
主要结局
VAS pain score
时间窗: 1, 4, 8 hours after operation and at discharge
次要结局
- Time to ambulation(following the procedure)
- Same day discharge(24 hours)
- VRS pain scores(Every 10 minutes in theatre recovery)
