Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time of first rescue analgesia post operatively
研究概览
简要总结
Study Title: Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Study Type: Interventional, Randomized, Double-Blind, Parallel comparative study
Objective: To compare the analgesic efficacy of ultrasound guided unilateral external oblique intercostal plane block versus local port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Participants: Adult patients aged 18–65 years, ASA physical status I–II, body mass index 18 - 30 kg/m² scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
Interventions:
- Group A: Patients will receive right sidedultrasound- guided external oblique intercostal plane block using 20 ml of 0.20% ropivacaine after induction of anaesthesia
- Group B: Patients will receive local infiltration at port site using 20 ml of 0.20% ropivacaine after induction of anaesthesia.
Primary Outcome: To evaluate and compare time to first rescue analgesia postoperatively
Secondary Outcomes:
- Hemodynamic parameters intraoperatively at 5, 30, 60, 90 minutes, at the end of surgery and postoperatively at 1, 6, 24 hours
- Intraoperative fentanyl (microgram) requirement
- Postoperative Numerical Rating Scale (NRS) score for pain at rest, deep breathing at 1, 6, 24 hours and on movement at 24 hours
- Total rescue analgesic requirement in first 24 hours
- Patient’s satisfaction score at 6 hours postoperatively
- Incidence of postoperative nausea and vomiting (PONV) in first 24 hours
Sample Size: 50 patients (25 per group) .
**Rationale:**EOIPB is a newer interfascial analgesic technique that anaesthetise lateral as well as anterior cutaneous branches of T6–T10 intercostal nerves and provides better outcomes in reducing postoperative pain and opioid consumption in post laparoscopic cholecystectomy patients.
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
- •1 Patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II 2 Body mass index 18 to 30 kg/m² 3 Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
排除标准
- •History of allergy or hypersensitivity to local anaesthetics
- •Infection at the site of needle insertion
- •Pregnant or lactating females
- •Patients with history of narcotic or alcohol addiction
- •Coagulopathy
- •Psychiatric disorders.
结局指标
主要结局
Time of first rescue analgesia post operatively
时间窗: Time of first rescue analgesia within first 24 hours post operatively
次要结局
- Hemodynamic Parameters(intraoperatively at 5,30,60 and 90 minutes and at end of surgery)
- Intraoperative fentanyl requirement (in micrograms)
- Numerical rating scale for postoperative pain(at rest, deep breathing (1,6,24 hours))
- Total rescue analgesic requirement in first 24 hours
- Incidence of postoperative nausea and vomitting in first 24 hours postoperatively
研究者
Dr Samiksha Kalra
ESIC Medical College and Hospital Faridabad