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
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)
