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临床试验/CTRI/2026/02/103765
CTRI/2026/02/103765尚未招募不适用

A prospective randomised controlled trial on the postoperative analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy

Sree Uthradom Thirunal Academy Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月15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
40
试验地点
1
主要终点
Pain scores using the NRS

研究概览

简要总结

This study will be conducted as a prospective, parallel-arm, randomized controlled trial done for a period of two years , comparing the postoperative analgesic efficacy of ultrasound-guided external oblique intercostal plane (EOI) block with port-site infiltration in patients undergoing laparoscopic cholecystectomy. Eligible patients will be randomly assigned to either Group A (EOI block) or Group B (port-site infiltration) using a computer-generated random number sequence. Allocation concealment will be ensured through sealed opaque envelopes. The investigator performing postoperative assessments will be blinded to group allocation. The final sample size will be 20 participants per group (total 40).Primary Outcome measures Pain scores at 1, 2, 6, 12, and 24 hours using the NRS. Secondary Outcomes are time to first intravenous rescue analgesic,total  dose of IV analgesic required in 24 hours,frequency  of IV analgesia administration, incidence of postoperative nausea and vomiting (PONV) , patient satisfaction score (Likert scale).

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

  • ASA Physical Status class 1 and 2 Undergoing elective laparoscopic cholecystectomy Providing written informed consent.

排除标准

  • Known allergy to local anesthetics Coagulopathy or local infection at injection site Chronic opioid use or major comorbid illnesses Refusal to give consent.

结局指标

主要结局

Pain scores using the NRS

时间窗: At 1 hour post extubation | 2 hours post extubation | 6 hours post extubation | 12 hours post extubation | 24 hours post extubation

次要结局

  • Time to first intravenous rescue analgesic(Total dose of IV analgesic required in 24 hours)

研究者

发起方
Sree Uthradom Thirunal Academy Of Medical Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sruthy Suresh

Sree Uthradom Thirunal Academy Of Medical Sciences

研究点 (1)

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