Comparison of Modified External Oblique Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity at rest
研究概览
简要总结
This prospective, randomized, assessor-blinded clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified External Oblique Intercostal Plane Block (EOIPB) in patients undergoing elective open nephrectomy under general anesthesia. Sixty adult patients will be randomized to receive either ESPB or EOIPB before surgical incision. All participants will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The study aims to determine whether one fascial plane block technique provides superior postoperative pain control and recovery following open nephrectomy.
详细描述
Open nephrectomy is associated with substantial postoperative pain that may impair recovery, delay mobilization, and increase opioid consumption. Regional anesthesia techniques have become important components of multimodal analgesia strategies aimed at improving postoperative outcomes while minimizing opioid-related adverse effects.
The erector spinae plane block (ESPB) and modified external oblique intercostal plane block (EOIPB) are ultrasound-guided fascial plane blocks that have demonstrated effectiveness in providing thoracoabdominal analgesia. However, evidence directly comparing these techniques in patients undergoing open nephrectomy remains limited.
This study is a prospective, randomized, controlled, assessor-blinded clinical trial conducted at a single tertiary academic center. Sixty patients aged 18 to 65 years with ASA physical status I-II who are scheduled for elective open nephrectomy will be enrolled and randomized in a 1:1 ratio to one of two study groups.
Participants assigned to the ESPB group will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Participants assigned to the EOIPB group will receive an ultrasound-guided modified external oblique intercostal plane block using the same volume and concentration of local anesthetic.
All patients will receive standardized general anesthesia, postoperative intravenous patient-controlled analgesia with tramadol, scheduled paracetamol, and rescue analgesics according to institutional protocols. Patients will be followed in the post-anesthesia care unit and at postoperative 2, 6, 12, and 24 hours.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be unaware of group allocation because all block procedures will be performed after induction of general anesthesia. Postoperative outcome assessments will be conducted by a researcher who is blinded to treatment 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
- •Age between 18 and 65 years.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Scheduled for elective open nephrectomy.
- •Able and willing to provide written informed consent.
- •Willing to comply with study procedures.
排除标准
- •Refusal to participate or inability to provide informed consent.
- •Emergency surgery.
- •Body mass index (BMI) greater than 35 kg/m².
- •Known allergy or hypersensitivity to local anesthetics.
- •Infection at the planned block insertion site.
- •Coagulopathy or ongoing anticoagulant therapy.
- •Pregnancy or breastfeeding.
- •Prisoners or other vulnerable populations unable to provide independent consent.
结局指标
主要结局
Pain intensity at rest
时间窗: 0, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity will be assessed at rest using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Pain intensity during movement(0, 2, 6, 12, and 24 hours after surgery)
- Total Opioid Consumption(24 hours after surgery)
- Rescue Analgesic Requirement(24 hours after surgery)
- Postoperative Nausea and Vomiting(24 hours after surgery)
- Heart Rate(From induction of anesthesia until the end of surgery)
- Mean Arterial Pressure(From induction of anesthesia until the end of surgery)
研究者
Onur Baran
Associate Professor of Anesthesiology and Reanimation
Namik Kemal University