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临床试验/NCT03413280
NCT03413280已完成不适用

The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月28日最近更新:
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
200
试验地点
1
主要终点
Difference of analgesic consumption between both group

研究概览

简要总结

The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults between the ages of 20 and 80
  • scheduled laparoscopic cholecystectomy patient
  • ASA class 1 or 2
  • Patients who have voluntarily agreed in writing to participate in the trial

排除标准

  • Patient with side effects on local anesthetics or steroids
  • Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  • Patients with uncontrolled medical or psychiatric problem
  • Patient does not agree to participate in the study
  • Patients who are pregnant or lactating
  • Patients whose visceral pain is expected to be too severe
  • Patients receiving a single laparoscopic cholecystectomy (including using a robot)

研究组 & 干预措施

preoperative Rectus sheath block: group Pre

Experimental

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

干预措施: Ultrasound guided Rectus sheath block (Drug)

preoperative Rectus sheath block: group Pre

Experimental

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

干预措施: Intercostal nerve block (Drug)

postoperative Rectus sheath block: group Post

Active Comparator

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision

干预措施: Ultrasound guided Rectus sheath block (Drug)

postoperative Rectus sheath block: group Post

Active Comparator

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision

干预措施: Intercostal nerve block (Drug)

结局指标

主要结局

Difference of analgesic consumption between both group

时间窗: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation) to compare.

次要结局

  • compare the Numeric rating scale (NRS)(at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Hyuk Lee

clinical assistant professor

Asan Medical Center

研究点 (1)

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