跳至主要内容
临床试验/CTRI/2024/11/076748
CTRI/2024/11/076748招募中不适用

Comparison of efficacy of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs Oblique subcostal transverse abdominis plane block (OSTAP) for postoperative pain relief in patients undergoing laparoscopic cholecystectomy.

Pt B D Sharma PGIMS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption.

研究概览

简要总结

This prospective randomised study will be conducted in 50 patients aged 18-65 years, either gender, ASA I-II undergoing elective laparoscopic cholecystectomy after obtaining institutional ethics committee approval,  CTRI registration and patients written informed consent. Patientrefusal of consent, coagulation disorder, infection at the injection site of the block, known allergy to local anaesthetics, chronic hepatic or renal failure, history of abdominal surgery or trauma, conversion of laparoscopic to open surgery, consumption of any pain killers within the 24 h before the operation, chronic opioid consumption, pregnancy, alcohol or drug abuse and body mass index (BMI) ≥ 35 kg m-2will be excluded. The aim of the study is to compare the efficacy of MTAPA with OSTAP block for postoperative pain relief. The primary objective is to compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption in the first 24 hours. The secondary objectives are to assess postoperative pain evaluation using Numeric Rating Scale (NRS) at 0 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively and at the time of rescue analgesic request, time to first rescue analgesic administration, number of thoracoabdominal dermatomes anaesthetised at 2 hrs after surgery and Adverse effects (if any). Patients will be randomized into 2 groups : Group O and Group M. Group O will be given OSTAP block bilaterally after induction of anaesthesia. Group M will be given MTAPA block bilaterally after induction of anaesthesia. Demographic data, evaluation of pain using NRS scale, time to first rescue analgesic, total rescue analgesic consumption, number of thoracoabdominal dermatomes anaesthetized and adverse effect, if any will be observed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patients of age between 18-65 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery under general anaesthesia will be included in the study.

排除标准

  • Refusal of consent.
  • Coagulation disorder.
  • Infection at the injection site of the block.
  • Known allergy to local anaesthetics.
  • Chronic hepatic or renal failure.
  • History of abdominal surgery or trauma.
  • Conversion of laparoscopic to open surgery.
  • Consumption of any pain killers within the 24 h before the operation.
  • Chronic opioid consumption.
  • Alcohol or drug abuse.
  • Body mass index (BMI) ≥ 35 kg m-2.

结局指标

主要结局

Compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption.

时间窗: Postoperative 24 hours

次要结局

  • Postoperative pain evaluation using Numeric Rating Scale (NRS)(0min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively.)
  • Time to first rescue analgesic(Postoperative 24 hrs)
  • Anesthetized thoracoabdominal dermatomes at 2 hours after surgery(Postoperative 2 hrs)
  • Adverse events(Postoperative 24 hrs)

研究者

发起方
Pt B D Sharma PGIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Jatin Lal

Pt B D Sharma PGIMS, Rohtak

研究点 (1)

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