Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)
研究概览
简要总结
Postoperative pain after cesarean section can significantly affect maternal recovery, early mobilization, and patient satisfaction. Regional anesthesia techniques are widely used to improve postoperative analgesia and reduce opioid consumption.
Combined spinal-epidural analgesia is commonly used for cesarean section and provides effective pain control but may be associated with technical difficulties and potential complications. The erector spinae plane block is a newer ultrasound-guided regional anesthesia technique that has shown promising results for postoperative pain management in various surgical procedures.
The aim of this study is to compare the postoperative analgesic effectiveness of combined spinal-epidural analgesia and the erector spinae plane block in patients undergoing elective cesarean section.
Pain intensity will be assessed using the visual analog scale at multiple postoperative time points. Maternal recovery will be evaluated using the Obstetric Quality of Recovery-11 questionnaire. Secondary outcomes will include postoperative nausea, pruritus, time to first analgesic request, mobilization time, and patient satisfaction.
This study will help determine whether the erector spinae plane block can provide comparable or improved postoperative pain control with fewer complications compared to combined spinal-epidural analgesia.
详细描述
Cesarean section is one of the most commonly performed surgical procedures worldwide and is frequently associated with moderate to severe postoperative pain. Effective postoperative analgesia is essential to promote early mobilization, maternal comfort, and improved recovery outcomes.
Combined spinal-epidural analgesia is widely used for cesarean section and provides reliable intraoperative anesthesia and postoperative pain control. However, this technique may be associated with technical complexity, prolonged procedure time, and potential complications such as hypotension, post-dural puncture headache, and catheter-related issues.
The erector spinae plane block is a relatively new ultrasound-guided interfascial plane block that provides multi-dermatomal analgesia by targeting dorsal and ventral rami of spinal nerves. Recent studies have demonstrated its effectiveness in various surgical procedures, including thoracic and abdominal surgeries.
This prospective interventional study will enroll 90 female patients aged 18 to 45 years with ASA physical status II undergoing elective cesarean section at Bursa City Hospital.
Participants will be allocated into two groups:
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-45 years
- •Scheduled for elective cesarean section under regional anesthesia
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Singleton pregnancy at term gestation
- •Ability to understand the study protocol and provide written informed consent
排除标准
- •Refusal to participate in the study
- •Contraindications to regional anesthesia (coagulopathy, infection at injection site, severe hypovolemia)
- •Known allergy to local anesthetics or study medications
- •Body mass index (BMI) > 40 kg/m²
- •Chronic opioid use or chronic pain disorders
- •Neurological disorders affecting sensory assessment
- •Severe obstetric complications (e.g., preeclampsia, placenta previa, fetal distress)
研究组 & 干预措施
Combined Spinal Epidural Analgesia Group
Participants receive combined spinal-epidural analgesia for cesarean section anesthesia and postoperative pain management according to institutional protocol.
干预措施: Combined Spinal Epidural Analgesia (Other)
Erector Spinae Plane Block Group
Participants receive spinal anesthesia for cesarean section followed by ultrasound-guided bilateral erector spinae plane block for postoperative analgesia.
干预措施: Ultrasound-Guided Erector Spinae Plane Block (Other)
结局指标
主要结局
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)
时间窗: 0, 1, 6, 12, and 24 hours postoperatively
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Dynamic VAS scores will also be recorded during movement.
次要结局
- Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)(Within the first 24 hours postoperatively)
- Time to First Analgesic Requirement(First 24 hours postoperatively)
- Postoperative Adverse Effects(Within the first 24 hours postoperatively)
研究者
eralp çevikkalp
Assistant Professor of Anesthesiology and Reanimation
Bursa City Hospital