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临床试验/CTRI/2013/07/003825
CTRI/2013/07/003825已完成4 期

A RANDOMISED CONTROLLED TRIAL COMPARING THE EFFICACY OF BUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY

Government Medical College and Hospital sector B chandigarh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年2月2日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To Assess relative efficacy of ropivacaine and bupivacaine for post operative analgesia using ultrasound guided TAP block in patients undergoing Laparoscopic cholecystectomy

研究概览

简要总结

Background :Ttransversus abdominis plane (TAP) block is a regional analgesic technique that blocks abdominal neural afferents by introducing local anaesthetic into the neurofascial plane between internal oblique and the transversus abdominis muscles thereby reducing the post operative pain of abdominal surgeries.

Method :  We evaluated the relative efficacy of bupivacaine 0.25% and ropivacaine 0.375% in ultrasound guided TAP block for postoperative analgesia in laparoscopic cholecystectomy. 60 adult ASA I & II patients undergoing elective laparoscopic cholecystectomy were randomized using computer coded sealed envelope to recieve either USG TAP block with 0.25% bupivacaine or 0.375% ropivacaine at the end of surgical procedure prior to extubation. All patients were assessed for postoperative pain, nausea vomiting and rescue analgesic consumption for upto 24 hours in the postoperative period.

Result : patients receiving USG TAP block with ropivacaine had significantly lower visual analog scale pain scores at 10 min, 30 min and 1 hour as compared to patients receiving USG TAP block with bupivacaine. beyond that both drugs are equal in their efficacy with respect to postoperative analgesia and 24 hrs cumulative rescue analgesic requirement. there were no complications attributable to TAP block.

Conclusion : USG TAP block is an effective regional analgesic technique for postoperative pain relief in patients undergoing laparoscopic cholecystectomy. ropivacaine has early onset of analgesia and provides better quality of pain relief in the immediate postoperative period upto 1 hour in comparison to bupivacaine. thereafter, both the drugs are equal in their efficacy in terms of postoperative analgesia and 24 gours cumulative rescue analgesic requirement.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •75 kg BW, Physical status ASA I and II.

排除标准

  • •pregnancy, drug allergy, drug abuse, Conversion to open Cholecystectomy, mentally unstable patient, coagulation abnormality, patients with abdominal drain in situ.

结局指标

主要结局

To Assess relative efficacy of ropivacaine and bupivacaine for post operative analgesia using ultrasound guided TAP block in patients undergoing Laparoscopic cholecystectomy

时间窗: 10 min, 30 mins, 1 hr, 4 hrs, 8hrs, 12hrs and 24 hours

次要结局

  • Assess post opeartive Nausea and vomiting, Calculate total rescue analgesic and antiemetic used(24hrs)

研究者

发起方
Government Medical College and Hospital sector B chandigarh
申办方类型
Government medical college

研究点 (1)

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