RANDOMIZED CONTROLLED TRIAL TO COMPARE THE POST-OPERATIVE PAIN AND RECOVERY CHARACTERISTICS USING CONVENTIONAL OPIOID BASED VERSUS OPIOID FREE ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY
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:
-
Time taken for extubation
-
Post-operative sedation score (Modified Ramsay Sedation Scale)
-
Incidence of PONV (Verbal Rating Scale)
-
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
Dr Akash Jain
Dr. Baba Saheb Ambedkar Medical College and Hospital, Rohini, Delhi
