Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) versus Port- Site local Infiltration and Opioid based Analgesia in Laparoscopic Cholecystectomy: A Prospective, Randomized Control Study"
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Postoperative pain scores using Numeric Rating Scale (NRS, 0–10)
研究概览
简要总结
This randomized, parallel group, active controlled clinical trial will evaluate the analgesic efficacy of ultrasound guided Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M TAPA) compared with conventional port site infiltration with local anesthetic in patients undergoing laparoscopic cholecystectomy. 113 adult patients (ASA I to III, aged 18 to 75 years) scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomized into two groups. Group A will receive bilateral M TAPA block after induction of anesthesia, while Group B will receive conventional port site infiltration with local anesthetic. The primary outcome will be postoperative pain scores assessed using the Numeric Rating Scale at predefined time intervals up to 24 hours. Secondary outcomes include total opioid consumption, intraoperative and postoperative hemodynamic responses, incidence of postoperative nausea and vomiting, sedation scores, return of bowel function, and patient satisfaction. This study aims to determine whether M TAPA provides superior analgesia, reduces opioid requirements, and improves recovery compared to routine practice.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Physical Status 1,2,3 Elective laparoscopic cholecystectomy under general anesthesia Patients who provide written informed consent.
排除标准
- •Patient refusal ASA 4 or higher Emergency or open cholecystectomy Coagulopathy or anticoagulant therapy Local infection at block site Allergy to local anesthetics Chronic opioid use or chronic pain disorder Severe hepatic or renal impairment.
结局指标
主要结局
Postoperative pain scores using Numeric Rating Scale (NRS, 0–10)
时间窗: At immediate post operative period or 0 hours, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours post operatively.
次要结局
- Total opioid consumption in 24 hours (IV tramadol/fentanyl equivalent) intraoperative and postopertive(cumulative intraoperative and postoperative)
- Hemodynamic response to surgical stimulus (MAP and HR)(At trocar insertion, 5, 10, 15 min after pneumoperitoneum, and at extubation)
- Hemodynamics in postoperative period (MAP and HR)(At 1, 2, 4, 8, 12, and 24 hours postoperatively)
- Incidence of postoperative nausea and vomiting (PONV)(0–24 hours postoperatively)
- Patient satisfaction score (Likert scale)(At 24 hours)
研究者
Degutla Karthik Chary
Department of anaesthesiology