Postoperative analgesic efficacy of USG guided bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A patient and observer blind randomized controlled intervention trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To evaluate the postoperative analgesic efficacy in the form of Numeric Rating Scale (NRS) for pain (rest)
研究概览
简要总结
This randomized patient and observer blind controlled intervention trial aims to evaluate whether EOIPB provides superior pain relief compared to standard systemic opioids and NSAIDs after laparoscopic cholecystectomy.
A total of 110 patients (55 per group) will be randomized to receive either standard postoperative analgesia alone or in combination with bilateral EOIPB using ropivacaine. The primary outcome is pain score at rest (NRS) at 6 hours post-surgery. Secondary outcomes include pain scores at multiple time intervals, fentanyl consumption, quality of recovery (QoR-15), hemodynamic variations, and side effects.
The trial employs strict randomization and blinding methods, and the sample size has been calculated to ensure adequate power. Results are expected to provide evidence on the role of EOIPB in improving postoperative pain management, reducing opioid use, and enhancing recovery
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
- •Patients aged
- •65 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective laparoscopic cholecystectomy surgeries under general anaesthesia.
排除标准
- ••Patient’s refusal •Known allergies to local anesthetic drugs, •ASA Grade more than 2 •Body mass index (BMI) more than 35 Kg per m2 •Participants having difficulty in the visualization of EO muscle on USG.
- ••Significant cerebrovascular, cardiovascular disease, hepatic or renal dysfunction or uncontrolled systemic illness •Known coagulation defects, or on anticoagulants •Infection in the intended intervention site, •Inability to communicate.
- ••Chronic opioid usage, having history of treatment of chronic pain condition and are on daily analgesic for more than 4 weeks.
- ••History of previous abdominal surgeries.
结局指标
主要结局
To evaluate the postoperative analgesic efficacy in the form of Numeric Rating Scale (NRS) for pain (rest)
时间窗: at 6 hours post surgery/post block
次要结局
- • To observe the Numeric Rating Score 1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs at rest and at movement.(at 1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs)
- To observe total Fentanyl consumption(in first 24 hours in both the groups.)
- To observe postoperative quality of Recovery Score (QoR-15).(24 hours)
- • Variations in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean)(1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs)
- • To observe the side effects and complications, if any, during and after the block procedure.(24 hours)
研究者
Priyanka Dwivedi
AIIMS Gorakhpur