Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain Intensity (Numeric Rating Scale - NRS)
研究概览
简要总结
The goal of this clinical trial is to determine whether the erector spinae plane (ESP) block provides better pain relief after flexible ureterorenoscopy (URS) surgery compared to standard analgesia alone. Researchers want to know:
Does the ESP block reduce pain levels in the first 24 hours after surgery?
Does it lower the need for opioid pain medication?
Does it reduce the need for additional (rescue) pain treatment?
Does it decrease the likelihood of postoperative nausea and vomiting (PONV)?
Participants will be randomly placed into one of two groups:
ESP Block Group: Participants will receive an ESP block using 20 mL of 0.25% bupivacaine under ultrasound guidance before surgery.
Control Group: Participants will receive standard pain management without a nerve block.
All participants will receive general anesthesia during surgery and multimodal pain management after surgery. Researchers will compare pain scores, opioid use, rescue analgesic needs, and the occurrence of nausea and vomiting between the two groups.
详细描述
Intervention Group (ESP Block): Patients will receive 20 mL of 0.25% bupivacaine (1:1 diluted with 0.5% bupivacaine) under ultrasound guidance at the T8-T10 level.
Control Group: No block will be performed, and patients will receive standard postoperative multimodal analgesia.
Procedure Description: The ESP block will be performed under sterile conditions with a high-frequency linear ultrasound probe. A 100-mm echogenic needle will be inserted in a cephalocaudal direction to deposit the local anesthetic deep to the erector spinae muscle at the transverse process level. The correct spread of the anesthetic will be confirmed via real-time ultrasound imaging.
All patients will receive standardized general anesthesia and multimodal analgesia.
Outcome measures include postoperative pain (NRS), opioid consumption, rescue analgesia requirement, and postoperative nausea and vomiting (PONV).
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
- 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
- •Patients undergoing elective flexible ureterorenoscopy (URS).
- •Age: 18-65 years.
- •Willing to participate and provide written informed consent.
排除标准
- •BMI >35 kg/m².
- •Allergy to local anesthetics.
- •Coagulation disorders or use of anticoagulants.
- •Patients requiring emergency surgery.
- •Patients with infection at the ESP block site.
研究组 & 干预措施
Control Group
Patients will receive routine multimodal analgesia without an ESP block.
ESP Block Group
A regional anesthesia technique in which 20 mL of 0.25% bupivacaine is injected under ultrasound guidance at the T8-T10 level to provide postoperative pain relief.
干预措施: Erector Spinae Plane (ESP) Block (Procedure)
结局指标
主要结局
Pain Intensity (Numeric Rating Scale - NRS)
时间窗: 0, 2, 6, 12, 24 hours postoperatively.
The Numeric Rating Scale (NRS, 0-10) will be used to assess postoperative pain intensity. Participants will be asked to rate their pain on a scale from 0 to 10, where: * 0 = No pain * 10 = Worst possible pain
次要结局
- Total Opioid Consumption (IV PCA Morphine Equivalent)(From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.)
- Postoperative Nausea and Vomiting (PONV)(From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.)
- Pain-Free Duration(From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.)
研究者
Onur Baran
Asst. Prof.
Namik Kemal University