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临床试验/CTRI/2024/07/070534
CTRI/2024/07/070534
尚未招募
不适用

Comparative evaluation of intraperitoneal instillation of 0.25% levobupivacaine with or without clonidine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy

Department of Anesthesia ESIC Medical College and Hospital Faridabad1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月22日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Department of Anesthesia ESIC Medical College and Hospital Faridabad
入组人数
90
试验地点
1
主要终点
To compare the duration of post-operative analgesia after intraperitoneal instillation of clonidine (0.75 mcg/kg) used as an adjunct to 0.25% levobupivacaine vs levobupivacaine alone in patients undergoing laparoscopic cholecystectomy in terms of duration of postoperative analgesia

概览

简要总结

This study is being conducted to compare the efficacy and safety of intraperitoneal instillation of clonidine (o.75mcg/kg) as an adjunct to 0.25% levobupivacaine in patients undergoing laparoscopic surgeries for post-operative analgesia. Patients of either sex, age 18 to 60 years and belonging to American Society of Anaesthesiologists (ASA) physical status I or II. Total 90 patients will be included in the study. Group A (n=45): will receive intraperitoneal instillation of 0.25% Levobupivacaine 28 ml + 2 ml normal saline (total volume = 30 ml); Group B (n =45): will receive intraperitoneal instillation of 0.25% Levobupivacaine 28 ml + Clonidine 0.75 mg/kg diluted with normal saline up to 2 ml (total volume = 30 ml).  Assessment of postoperative pain using 10 point visual analogue scale(VAS) score (Score 0: no pain and Score 10: worst possible pain) at 30 mins, 1 hour, 2hours 6 hours,12 hours and 24 hours after surgery. Diclofenac sodium aqueous (75 mg IV) will be given as rescue analgesic when VAS ≥4 or on patient demand.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex, age 18 to 60 years and belonging to American Society of Anaesthesiologists (ASA) physical status I or II.

排除标准

  • Known allergy to study drugs Pregnant and lactating females Procedure converted to open cholecystectomy.

结局指标

主要结局

To compare the duration of post-operative analgesia after intraperitoneal instillation of clonidine (0.75 mcg/kg) used as an adjunct to 0.25% levobupivacaine vs levobupivacaine alone in patients undergoing laparoscopic cholecystectomy in terms of duration of postoperative analgesia

时间窗: At different time intervals during first 24 hours

次要结局

  • 1) Total rescue analgesic consumption(2) Postoperative VAS score)

研究者

发起方
Department of Anesthesia ESIC Medical College and Hospital Faridabad
申办方类型
Other [ESIC Medical College and Hospital, Faridabad]
责任方
Principal Investigator
主要研究者

Dr Saurav Sagar

ESIC Medical College and Hospital Faridabad

研究点 (1)

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