Efficacy of Bilateral Erector Spinae Plane Block Versus Bilateral External Oblique Intercostal Plane Block for Perioperative Analgesia in Open Cholecystectomy Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Postoperative Pain Score (VAS)
研究概览
简要总结
This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.
Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.
This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.
详细描述
Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.
Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.
In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.
All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.
The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study is double-blinded. The anesthesiologist performing the block is not involved in intraoperative management or postoperative assessment. Patients, intraoperative care providers, and outcome assessors are blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 years.
- •Patients scheduled for elective open cholecystectomy.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Patients who provide informed consent.
排除标准
- •Patient refusal.
- •Known allergy to local anesthetics.
- •Coagulopathy or anticoagulant therapy.
- •Infection at the site of injection.
- •Severe hepatic, renal, or cardiac disease.
- •Body mass index (BMI) > 35 kg/m².
- •Pregnancy.
研究组 & 干预措施
Erector Spinae Plane Block Group
Participants in this group will receive bilateral erector spinae plane block using local anesthetic for postoperative analgesia following open cholecystectomy.
干预措施: Erector Spinae Plane Block (Procedure)
External Oblique Intercostal Plane Block Group
Participants in this group will receive bilateral external oblique intercostal plane block using local anesthetic for postoperative analgesia following open cholecystectomy.
干预措施: External Oblique Intercostal Plane Block (Procedure)
结局指标
主要结局
Postoperative Pain Score (VAS)
时间窗: Within the first 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.
次要结局
- Total Opioid Consumption(First 24 hours postoperatively)
- Time to First Analgesic Request(Within 24 hours postoperatively)
- Postoperative Complications(Within 24 hours postoperatively)
研究者
Salaheldin Ahmed Abdelziz
Anesthesia specialist
Sohag University