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临床试验/CTRI/2025/11/098007
CTRI/2025/11/098007尚未招募4 期

Comparison of modified thoracoabdominal nerve block (MTAPA) vs external oblique plane block (EOI) in patients undergoing laparoscopic cholecystectomy: A prospective randomized controlled trial.

AIIMS Nagpur Department of Anesthesiology1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年12月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
75
试验地点
1

研究概览

简要总结

This single center prospective randomized clinical trial is being conducted at the department of anaesthesiology aiims nagpur to compare the postoperative analgesic efficacy of ultrasound guided modified thoracoabdominal nerves block through perichondrial approach mtapa and external oblique intercostal eoi block in patients undergoing elective laparoscopic cholecystectomy. Despite laparoscopic cholecystectomy being a minimally invasive procedure postoperative pain remains a significant concern attributed to incisional visceral and peritoneal pain mechanisms. Multimodal analgesia including regional anesthesia techniques has emerged as a key strategy in postoperative pain control.This study hypothesizes that the mtapa block by targeting thoracoabdominal nerves from T4 to T12 dermatomes will offer superior analgesic outcomes and reduce opioid consumption compared to the eoi block which targets the lateral and anterior cutaneous branches of intercostal nerves T6 to T11. Seventy adult patients aged 18 to 65 years and classified as asa physical status I and II will be randomized into two groups of 34 each. Both blocks will be performed using ultrasound guidance by a trained anesthesiologist while postoperative pain scores and opioid consumption will be assessed by a blinded observer.

Primary outcome is total opioid consumption within 24 hours postoperatively. Secondary outcomes include intraoperative and postoperative hemodynamic stability, pain scores atvarious time intervals using the numerical rating scale and assessment of recovery using a questionnaire. Any adverse effects such as nausea vomiting or bradycardia will also be recorded. Data will be statistically analyzed using a statistical software. This study aims to provide evidence on the comparative efficacy of mtapa and eoi blocks in enhancing postoperative recovery and analgesia potentially guiding future anesthesia protocols for laparoscopic surgeries.

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

  • 1- Patients classified as American society of Anesthesiologists (ASA) physical status I-II.
  • 2- Patients scheduled for elective laparoscopic cholecystectomy.

排除标准

  • 1- Patients on anticoagulant therapy 2- Presence of coagulopathy 3- Known allergies to local anesthesia 4- Local infection at block site 5- Inability to comprehend or assess pain ratings and recovery quality scoring systems.

研究者

发起方
AIIMS Nagpur Department of Anesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nidhi Swaroop

All Inida Institute of Medical Sciences Nagpur

研究点 (1)

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