Comparison of EXORA Block and Epidural Analgesia on Quality of Recovery and Postoperative Analgesia Following Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NRS
研究概览
简要总结
This prospective observational study aims to compare the effects of the EXORA block and epidural analgesia on postoperative pain control and quality of recovery in patients undergoing gynecological surgery. Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, and postoperative pain will be evaluated using the Visual Analog Scale (VAS).
详细描述
Effective postoperative analgesia is essential for improving recovery quality and patient satisfaction following gynecological surgery. Epidural analgesia is widely accepted as a standard technique for postoperative pain control; however, it may be associated with adverse effects such as hypotension and delayed mobilization. The EXORA block is an ultrasound-guided fascial plane block that has recently emerged as an alternative analgesic technique with a potentially favorable safety and recovery profile.
This prospective observational study compares postoperative recovery quality and analgesic efficacy between patients receiving EXORA block and those receiving epidural analgesia for postoperative pain management. Recovery quality will be objectively evaluated using the validated Quality of Recovery-15 (QoR-15) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Adults aged 18 to 80 years
- •ASA (American Society of Anaesthetists) physical status classification I-III
- •Undergoing elective gynecological surgery
- •Receiving either EXORA block or epidural analgesia for postoperative pain management
排除标准
- •Secondary or repeat surgical procedures
- •Severe renal or hepatic dysfunction
- •Body mass index (BMI) greater than 30 kg/m²
- •Psychiatric or cognitive disorders impairing cooperation or questionnaire completion
研究组 & 干预措施
Group : exora block
Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice.
干预措施: Tramadol (Drug)
Group : exora block
Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice.
干预措施: exora block (Procedure)
Group:Epidural Analgesia
Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols.
干预措施: Tramadol (Drug)
Group:Epidural Analgesia
Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols.
干预措施: epidural (Procedure)
结局指标
主要结局
NRS
时间窗: Postoperative 24 hours
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
次要结局
- Quality of Recovery-15 (QoR-15) Score(Postoperative 24 hours)
- Total Postoperative Tramadol Consumption (mg)(Postoperative 24 hours])
- Incidence and Severity of Postoperative Nausea and Vomiting Assessed by the Nausea and Vomiting Scale (NVS)(Postoperative 24 hours)
- Number of Participants Requiring Additional Postoperative Rescue Analgesia(postoperative 24 hour)
- pinprick test(postoperative 24 hour)
研究者
Korgün Ökmen
Principal Investigator
Bursa Yuksek Ihtisas Training and Research Hospital