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临床试验/CTRI/2024/01/061269
CTRI/2024/01/061269尚未招募4 期

A comparison between ultrasound guided bilateral subcostal transversus abdominis plane block versus intraperitoneal instillation of local anaesthetic for postoperative analgesia in laparoscopic cholecystectomy patients: A prospective randomised comparative clinical study

Medical College Baroda1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月15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
80
试验地点
1
主要终点
To compare the duration of postoperative analgesia between two groups

研究概览

简要总结

The aim of our study is to evaluate and compare the efficacy of postoperative analgesia provided by Transversus Abdominis Plane block and intraperitoneal instillation of local anaesthetic solution in patients who are undergoing laparoscopic cholecystectomy. 80 patients belonging to the age group 18 to 70 years with ASA status I, II or III are randomly selected into two groups. Group T are those patients who received Ultrasound guided bilateral subcostal Transversus Abdominis plane block using 30mL of 0.25% Bupivacaine local solution just after the induction of general anaesthesia and Group L are those who received intraperitoneal instillation of 30mL of 0.25% of Bupivacaine local solution under vision just after trocar insertion and before the start of the surgery. Intraoperative hemodynamic stability is monitored among the two groups by monitoring the HR,BP,SpO2 and EtCO2. Postoperatively the time taken for the administration of the first dose of rescue analgesia at VAS >=4 is also noted among the two groups. The total amount of postoperative analgesic requirement in 24 hours time period and the VAS scores at 2,4,6,8, 12 and 24 hours are also compared among the two groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I II III BMI less than or equal to 30 kg per meter square.

排除标准

  • Patients who refused consent to be part of clinical study Patients with allergy to local anaesthetics Infection at the site of injection Coagulopathy Duration of surgery for more than 3 hours Laparoscopic surgeries that gets converted into open cholecystectomy.

结局指标

主要结局

To compare the duration of postoperative analgesia between two groups

时间窗: Time required for administration of first postoperative rescue analgesia in VAS score more than 4

次要结局

  • To monitor intraoperative hemodynamic stability(1min, 5min, 10min, 30min, 60min, 90min, 120min, 150min, 180min)
  • To assess VAS score postoperatively(2hours, 4 hours, 6hours, 8hours, 12hours, 24hours)
  • Total amount of postopeative analgesia administered(24 hours postoperatively)

研究者

发起方
Medical College Baroda
申办方类型
Government medical college

研究点 (1)

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