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临床试验/CTRI/2025/09/094886
CTRI/2025/09/094886
尚未招募
不适用

Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy: A SINGLE BLIND randomized controlled trial.

Govt Medical College1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年12月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Govt Medical College
入组人数
92
试验地点
1
主要终点
a. Hemodynamic profile (heart rate and mean blood pressure) in the intraoperative period

概览

简要总结

Laparoscopic cholecystectomy is the standard treatment for gallstone disease, yet many patients still experience moderate-to-severe postoperative pain. Opioid-based analgesia, though effective, is limited by side effects such as respiratory depression, nausea, vomiting, and delayed recovery, making multimodal, opioid-sparing strategies preferable. The erector spinae plane block (ESPB), first described in 2016, has shown promising results in thoracic and upper abdominal surgeries, but evidence in laparoscopic cholecystectomy remains limited. This randomized controlled trial aims to evaluate the analgesic efficacy of ESPB combined with port-site infiltration compared with port-site infiltration alone in adult patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to receive either ultrasound-guided ESPB at the T7–T8 level with port-site infiltration or port-site infiltration alone, with standardized general anesthesia and non-opioid analgesia in both groups. The primary outcome is the time to first rescue analgesia within 24 hours, with intraoperative fentanyl consumption as a key secondary outcome. Additional endpoints include postoperative opioid use, pain scores, incidence of postoperative nausea and vomiting, recovery quality, and block-related complications. Approximately ninety-two patients will be enrolled to detect a clinically significant difference with adequate power. By assessing whether ESPB can reduce perioperative opioid requirements and prolong postoperative analgesia, this study seeks to establish its role in enhancing multimodal pain management for laparoscopic cholecystectomy. Our research hypothesis will be Ultrasound guided erector spinae block may reduce the requirement of intraoperative fentanyl consumption and increase the time of 1st rescue analgesic dose.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists Physical Status I and II b.
  • Age between 18 and 60 years old undergoing laparoscopic cholecystectomy.

排除标准

  • refusal for regional anaesthesia b.
  • patient having infection at site of injection c.
  • patients having coagulopathy and platelet count less than 1 lakh per cmm d.
  • patients with a known allergy to local anaesthetics.
  • pregnancy, f.
  • body mass index more than 35 kg per m2, g.
  • chronic pain h.
  • hepatic or renal dysfunction( Srerum creatinine more than 1.2 ;liver enzymes exceeding normal limit).

结局指标

主要结局

a. Hemodynamic profile (heart rate and mean blood pressure) in the intraoperative period

时间窗: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours

b. Mean total dose of fentanyl during the intraoperative period during laparoscopic cholecystectomy

时间窗: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours

c. Time to requirement of first rescue analgesic (inj Diclofenac 75mg iv) when VAS score more than 4.

时间窗: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours

次要结局

未报告次要终点

研究者

发起方
Govt Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nairita Mayur

College of Medicine & Sagore Dutta Hospital

研究点 (1)

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