The Effect of Bilateral Lumbar Erector Spinae Plane Block on Postoperative Analgesia in Lumbar Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- VAS values of patients in the first 24 hours postoperatively
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are:
Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur.
Participants:
Patients in this study will be asked to:
Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy
Undergo postoperative follow-up including:
measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects
详细描述
This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia.
Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 and over, 80 and under
- •American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ
- •Patients who can cooperate and give consent
- •No chronic analgesic or opioid use
- •No mental or psychiatric disorders
- •No alcohol or illicit drug use
- •Patients scheduled for elective spinal surgery
排除标准
- •-Patients who withdrew from participation at any time during the study
- •Foreign nationals who could not be contacted
- •Patients under 18 and over 80
- •Patients with an ASA score of Ⅳ or higher
- •Patients scheduled for emergency surgery
- •Pregnant women and breastfeeding mothers
- •Bleeding diathesis
- •Drug allergy
- •Anticoagulant use
- •Local/systemic infection
- •Serious arrhythmia
研究组 & 干预措施
ESP BLOCK,
干预措施: ESP block group (Procedure)
CONTROL GROUP
结局指标
主要结局
VAS values of patients in the first 24 hours postoperatively
时间窗: The first 24 hours postoperatively
Zero indicates no pain, and 10 indicates the worst possible pain
次要结局
未报告次要终点
研究者
MERVE KAYNAK
specialist doctor
Afyonkarahisar Health Sciences University