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临床试验/NCT01090882
NCT01090882已完成不适用

Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial

University Hospitals Coventry and Warwickshire NHS Trust1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

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

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 Comparator

Sham wash, sham injection

干预措施: 0.9% normal saline solution (Drug)

Subperitoneal injection

Experimental

Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder

干预措施: Bupivocaine (Drug)

Topical LA

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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