Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total postoperative rescue analgesic (opioid) consumption.
研究概览
简要总结
This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia
详细描述
Severe pain after pilonidal sinus surgery is a significant problem that reduces patient comfort. In this randomized, prospective study, patients will be divided into two groups (Sacral ESPB group and control group) using a computer randomization method before the surgery. In the Sacral ESPB group, the block will be performed under ultrasound guidance using a 20 ml local anesthetic volume immediately after the surgical procedure and before extubation. The study will compare postoperative rescue analgesic requirement, opioid consumption, pain scores (NRS), and the incidence of side effects and complications
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)
盲法说明
Single Blind (Outcomes Assessor). Postoperative patient evaluation will be performed by another anesthesiologist who was not involved in the procedure.
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 scheduled for elective pilonidal sinus surgery.
- •ASA physical status I and II
排除标准
- •Allergy or sensitivity to local anesthetics or opioid drugs.
- •Infection at the block site.
- •Alcohol or drug addiction.
- •Use of anticoagulant agents.
- •Patient refusal.
研究组 & 干预措施
Sacral ESPB Group
干预措施: Sacral Erector Spinae Plane Block (Procedure)
Control Group
干预措施: Standard Postoperative Analgesia (Drug)
结局指标
主要结局
Total postoperative rescue analgesic (opioid) consumption.
时间窗: At 24 hours postoperatively (Cumulative total over the 24-hour period)
Total amount of intravenous tramadol administered as a rescue analgesic will be recorded
次要结局
- Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)(At 1, 3, 6, 12, 18, and 24 hours postoperatively.)
- Incidence of opioid-related side effects and block-related complications.(During the 24-hour postoperative period.)
研究者
Burak Omur
Assistant Professor
Medipol University