Evaluation of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block on Postoperative Pain and Bleeding in Major Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative estimated blood loss
研究概览
简要总结
This study aims to evaluate the effects of ultrasound-guided bilateral erector spinae plane block on intraoperative pain control and bleeding in patients undergoing major spinal surgery. Participants will be randomly assigned to two groups: one group will receive the Erector Spinae Plane block, while the other group will receive standard pain management. Primary outcomes include postoperative pain levels and intraoperative blood loss. This study seeks to determine whether the Erector Spinae Plane Block technique positively contributes to patient recovery and reduces bleeding complications.
详细描述
This randomized controlled trial investigates the effectiveness of ultrasound-guided bilateral Erector Spinae Plane Block on intraoperative opioid consumption and bleeding in patients undergoing spinal surgery. Eligible adult patients will be enrolled after obtaining informed consent.
Participants will be randomly assigned to two groups: the intervention group will receive bilateral Erector Spinae Plane Block under ultrasound guidance before surgery, while the control group will receive standard pain management without the block. The Erector Spinae Plane Block will be performed using a standard dose of bupivacaine.
The primary outcome measure is the amount of intraoperative bleeding. Secondary outcomes include opioid consumption and incidence of complications.
This study aims to provide evidence on the efficacy of the Erector Spinae Plane Block technique in improving postoperative recovery and reducing bleeding complications in major spinal surgeries.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group assignments. An anesthesiologist not involved in postoperative data collection will perform the Erector Spinae Plane Block.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Scheduled for elective spinal stabilization surgery
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Provided written informed consent
排除标准
- •Coagulopathy or current anticoagulant therapy
- •Anatomical barrier or infection at the Erector Spinae Plane Block site
- •Known allergy to local anesthetics or opioids
研究组 & 干预措施
Erector Spinae Plane Block Group
Participants in this group received an ultrasound-guided Erector Spinae Plane Block preoperatively as part of multimodal analgesia.
干预措施: Ultrasound-guided erector spinae plane block (Procedure)
Control Group
Participants in this group did not receive a preoperative regional anesthesia block. Standard postoperative analgesic protocols were used.
结局指标
主要结局
Intraoperative estimated blood loss
时间窗: During surgery
Intraoperative estimated blood loss (milliliters) Total amount of blood lost during surgery will be measured in milliliters. \[Time Frame: During surgery\]
次要结局
- Total intraoperative remifentanil consumption(During surgery)
研究者
Funda Atar
Principal Investigator
Ankara Etlik City Hospital