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临床试验/NCT03543202
NCT03543202已完成不适用

Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年6月10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
发起方
入组人数
72
试验地点
1
主要终点
Postoperative analgesia

研究概览

简要总结

Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction

详细描述

Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time)

Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

patients and outcome assesors will be blinded for the analgesia method

入排标准

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

入选标准

  • Clinical diagnosis of biliary disease

排除标准

  • Uncooperative patients
  • Blood coagulation disorders
  • Laparatomy
  • Obesity: body mass index >35
  • Renal failure
  • Hepatic failure
  • Emergency surgery
  • Pregnancy

研究组 & 干预措施

Transversus abdominis plane block

Experimental

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

干预措施: Transversus abdominis plane block (Drug)

Transversus abdominis plane block

Experimental

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

干预措施: Intravenous patient controlled analgesia (Drug)

Local infiltration anesthesia

Active Comparator

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

干预措施: local infiltration anesthesia (Drug)

Local infiltration anesthesia

Active Comparator

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

干预措施: Intravenous patient controlled analgesia (Drug)

Intravenous patient control analgesia

Sham Comparator

will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia

干预措施: Intravenous patient controlled analgesia (Drug)

结局指标

主要结局

Postoperative analgesia

时间窗: Postoperative day 1

Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain)

次要结局

  • Patient satisfaction(Postoperative 24 th hour)
  • Postoperative nausea and vomiting (PONV)(Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emine Arik

Specialist in Anesthesia

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

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