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临床试验/NCT01595165
NCT01595165Unknown不适用

Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial

Soonchunhyang University Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Numerical Rating Scale (NRS) 15 min after entering recovery room

研究概览

简要总结

Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.

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)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-65 patients scheduled elective laparoscopic cholecystectomy

排除标准

  • Patient refusal
  • Allergy to ropivacaine
  • Coagulopathy
  • Morbid obesity (BMI>35 kg/m2)
  • Previous abdominal surgery.

研究组 & 干预措施

Control

Placebo Comparator

Control group receiving saline instead of ropivacaine

干预措施: Placebo Ultrasound guided subcostal TAP block (Procedure)

TAP

Experimental

TAP group receiving ropivacaine total of 150 mg at TAP under US

干预措施: Ultrasound guided subcostal TAP block (Procedure)

结局指标

主要结局

Numerical Rating Scale (NRS) 15 min after entering recovery room

时间窗: 15 min after entering recovery room

次要结局

  • Fentanyl consumption at recovery room(Up to 3 hours until discharge from recovery room)
  • Recovery room stay(Up to 3 hours from entering recovery room to discharge)
  • Incidence of postoperative nausea and vomiting (PONV)(Up to 3 hours during recovery room stay)
  • NRS at 4h, 24h, and 48 h after surgery(4h, 24h, and 48 h after surgery)

研究者

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

Kim Sang-Hyun

Associate professor

Soonchunhyang University Hospital

研究点 (2)

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