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临床试验/CTRI/2026/02/104558
CTRI/2026/02/104558尚未招募不适用

RANDOMIZED CONTROLLED TRIAL TO COMPARE THE POST-OPERATIVE PAIN AND RECOVERY CHARACTERISTICS USING CONVENTIONAL OPIOID BASED VERSUS OPIOID FREE ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY

Dr Baba Saheb Ambedkar Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年3月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
Comparing post-operative pain using opioid free anesthesia (intravenous dexmedetomidine , ketamine and laparoscopic guided transversus abdominis plane block) versus conventional opioid based anesthesia for laparoscopic cholecystectomy with the help of Visual Analogue Scale every 4 hours and total amount of analgesic required in 1st 24 hours

研究概览

简要总结

Currently, there is a paucity of randomized controlled trials that directly compare the efficacy of

conventional opioid-based anaesthesia with OFA incorporating laparoscopic TAP blocks during

laparoscopic cholecystectomy in terms of postoperative pain control, recovery metrics, opioid

consumption, PONV, and patient satisfaction.

Therefore, this study is being done to contribute supportive evidence to the existing literature on

whether an opioid free anaesthesia approach incorporating laparoscopic-guided TAP block

provides superior postoperative outcomes compared to the conventional opioid based anesthesia

in laparoscopic cholecystectomy.

Study area:

The study will be conducted in the operation theatre complex, Department of

Anaesthesiology & Critical care at Dr. Baba Saheb Ambedkar Medical college and

Hospital, Sector-6, Rohini, Delhi.

Primary Objective:

Comparing post-operative pain using opioid free anesthesia (intravenous dexmedetomidine ,

ketamine and laparoscopic guided transversus abdominis plane block) versus conventional

opioid based anesthesia for laparoscopic cholecystectomy using –

a) Visual Analogue Scale (VAS) every 4 hour till 24 hours

b) Total amount of analgesic requirement in 24 hours

Secondary Objectives:

Compare both groups regarding:

  1. Time taken for extubation

  2. Post-operative sedation score (Modified Ramsay Sedation Scale)

  3. Incidence of PONV (Verbal Rating Scale)

  4. Patient satisfaction (QoR-15 Scale)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Age :18-60 years of both gender
  • American Society of Anesthesiologists (ASA) physical status I and II
  • BMI : 18.5-30 kg/m2.

排除标准

  • Patient with known case of coagulopathy, cardiovascular, hepatic, pulmonary, psychological or neurological diseases
  • History of psychiatric illness or inability to assess pain
  • Patient allergic to study drugs
  • Pregnant and lactating women.

结局指标

主要结局

Comparing post-operative pain using opioid free anesthesia (intravenous dexmedetomidine , ketamine and laparoscopic guided transversus abdominis plane block) versus conventional opioid based anesthesia for laparoscopic cholecystectomy with the help of Visual Analogue Scale every 4 hours and total amount of analgesic required in 1st 24 hours

时间窗: 3 months

次要结局

  • Compare both groups regarding recovery characteristics -(1) Time taken for extubation)

研究者

发起方
Dr Baba Saheb Ambedkar Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Akash Jain

Dr. Baba Saheb Ambedkar Medical College and Hospital, Rohini, Delhi

研究点 (1)

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