Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Tramadol consumption
研究概览
简要总结
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.
The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age between 18 and 65 years
- •Undergoing elective laparoscopic cholecystectomy
- •Classified as American Society of Anesthesiologists (ASA) physical status I to III
- •Providing written informed consent
排除标准
- •Known allergy or hypersensitivity to local anesthetics
- •Infection or skin lesions at the site of block application
- •Emergency surgical procedures
- •Refusal to participate in the study
- •Uncontrolled arterial hypertension
- •Uncontrolled diabetes mellitus
- •Mental retardation
- •Current use of antidepressant medications
- •Presence of metabolic disorders
- •Known bleeding diathesis
- •Morbid obesity (Body Mass Index > 40 kg/m²)
研究组 & 干预措施
Group ESP
The ESP block will be performed approximately 30 minutes before general anesthesia induction following sedation and standard monitoring. All block procedures will be conducted under sterile conditions, with skin preparation using dermol (%70 Isopropyl Alcohol, %2 Chlorhexidine Gluconate) and the ultrasound probe covered with a sterile drape.
干预措施: Group ESP (Procedure)
Group EXORA
The EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring.
干预措施: Group EXORA (Procedure)
结局指标
主要结局
Tramadol consumption
时间窗: 12 and 24 hours
Total tramadol used in the first 12 and 24 hours postoperatively.
次要结局
- Visual Analog Scale (VAS) for Pain Assessment(30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery)
- Pinprick Sensory Block Test Results(10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery)
- Nausea and Vomiting Score (NVS)(Within 24 hours after surgery)
- Ramsay Sedation Scale (RSS)(Within 24 hours after surgery)
- Additional Analgesic Consumption(Within 24 hours after surgery)
- Visual Analog Scale (VAS) for Pain Assessment(30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery)
研究者
Aycan KURTARANGİL DOĞAN
Principal Investigator
Kutahya City Hospital