跳至主要内容
临床试验/CTRI/2025/07/091732
CTRI/2025/07/091732尚未招募不适用

Preemptive Ultrasound guided Modified Thoracoabdominal nerve block via perichondrial approach (M - TAPA) vs oblique subcostal transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia - A Randomised controlled trial

Dr B R Ambedkar medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月4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
60
试验地点
1
主要终点
To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups

研究概览

简要总结

Laparoscopic cholecystectomy (LC) is a frequently performed surgery as the gold standard in the treatment of symptomatic gallstone disease. Despite the introduction of a  minimally invasive approach, cholecystectomy can cause significant postoperative pain owing to multifactorial factors.  Acute postoperative pain is the most common cause of patient discomfort during the period after LC and is the most common cause of readmission after discharge. Poorly controlled postoperative pain impairs the quality of recovery, increasing the risk of postoperative pulmonary complications as risk factor for the formation of chronic pain. It was observed that the abdominal pain following LC mostly originates from the incision area, and the remaining part consists of visceral and referred pain. Multimodal analgesia, including opioids is used to limit pain following LC. Treatment with opioids might cause side effects for example postoperative nausea and vomiting, constipation, respiratory depression. Oblique subcostal transverse abdominis plane block (OSTAP) provides a wide range of analgesia from T7 – T12, is effective for 6 – 18h postoperatively, however it requires multiple injections to achieve complete analgesia. Modified thoracoabdominal nerve block through perichondrial approach (M – TAPA)  is a newer technique which has received increasing attention due to its wide range of analgesic coverage of the trunk (that is T5 – T12)  with a single puncture per side and has been  reported to provide a long acting effect. M – TAPA offers blocking both anterior and lateral cutaneous branches of the thoracoabdominal nerves, surpassing the limitations of conventional techniques such as transversus abdominis plane block. We hypothesize that M – TAPA block would be more effective than OSTAP block for controlling postoperative pain, considering its range of efficacy and long term durability.

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 75.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective laparoscopic cholecystectomy under general anaesthesia.
  • Patients aged between 18 to 75y.
  • Patients belonging to American Society of Anaesthesiologists physical status (ASA.
  • PS) 1 and 2.

排除标准

  • Known allergy to the local anaesthetics given.
  • Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
  • Patients with dementia or cognitive problems.
  • Patients with BMI more than 35 kg/m
  • Patients who are known case of diabetes mellitus.

结局指标

主要结局

To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups

时间窗: The time period from administration of block till first rescue analgesia for first 24 postoperative hours

次要结局

  • To compare total analgesic consumption during postoperative period over 24 hours in both groups.(To assess the adverse effects associated with analgesics such as nausea, vomiting.)

研究者

发起方
Dr B R Ambedkar medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Deepak Vijaykumar Kadlimatti

Dr B R Ambedkar medical college and hospital

研究点 (1)

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