Comparison of Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Biportal Endoscopic Discectomy: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medipol University
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (NRS) at 6th hour.
概览
简要总结
The aim of this study is to compare the analgesic efficacy of ultrasound-guided (USG) lumbar Erector Spinae Plane Block (ESPB) performed by an anesthesiologist versus a "free-hand" ESPB performed intraoperatively by the surgeon in patients undergoing Unilateral Biportal Endoscopic Discectomy (UBE). The investigators hypothesize that Us-guided would provide more effective analgesia, and USG-guided application might provide more precise local anesthetic spread.
详细描述
Unilateral Biportal Endoscopic Discectomy (UBE) has emerged as a minimally invasive and effective surgical technique for lumbar disc herniation, offering advantages such as reduced tissue trauma and faster recovery. However, despite its minimally invasive nature, patients may still experience significant postoperative pain, which can delay mobilization and discharge. The Erector Spinae Plane Block (ESPB) is a versatile regional anesthesia technique that has gained popularity for providing effective analgesia in spinal surgeries by targeting the dorsal rami of spinal nerves.
Conventionally, ESPB is performed by anesthesiologists using ultrasound guidance (USG) before or after the surgical procedure. However, in the context of UBE, the surgeon also has direct or endoscopic access to the anatomical landmarks required for the block. A "free-hand" ESPB performed intraoperatively by the surgeon under direct vision could potentially save time and provide similar analgesic benefits without the need for additional ultrasound equipment or preoperative intervention by the anesthesiologist.
The aim of this randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided (USG) lumbar ESPB performed by an anesthesiologist versus a free-hand ESPB performed intraoperatively by the surgeon in patients undergoing UBE surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcomes Assessor and participant were blinded to the study
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II.
- •Scheduled for elective UBE surgery.
排除标准
- •Infection at the injection site.
- •Coagulopathy or bleeding disorders.
- •Allergy to local anesthetics.
- •Chronic opioid use.
- •Cognitive dysfunction.
研究组 & 干预措施
Group US-ESPB
Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist.
干预措施: US-guided ESPB. (Drug)
Group Surgeon-ESPB
Patients in this group received a free-hand (intraoperative) lumbar Erector Spinae Plane Block performed by the neurosurgeon.
干预措施: Surgeon-performed (Free-hand) ESPB. (Drug)
结局指标
主要结局
Postoperative Pain Score (NRS) at 6th hour.
时间窗: 6 hours after surgery.
Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain).
次要结局
- Rescue Analgesic Consumption(Postoperative 24 hours period)
- Opioid-related Side Effects(Postoperative 24 hours period)
- Postoperative Pain Score / NRS at other intervals(Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours)
研究者
Bahadir Ciftci
Principal Investigator
Medipol University