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临床试验/NCT03767816
NCT03767816已完成不适用

The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月17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
60
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 erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.

After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.

NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected

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
  • American society of anesthesiologists score 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 with deformity at vertebra or chest wall.
  • Patients who are pregnant or lactating
  • Patients receiving a single laparoscopic cholecystectomy (including using a robot)
  • Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

研究组 & 干预措施

Group R : Rectus sheath block group

Experimental

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision

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

Group RE: Rectus sheath block and erector spinae plane block

Active Comparator

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml

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

Group RE: Rectus sheath block and erector spinae plane block

Active Comparator

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml

干预措施: Ultrasound erector spinae plane 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, 12, 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, 12, 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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