Postoperative Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plane Block versus Local InfiltrationAnalgesia in Patients Undergoing Lumbar Spine Fixation under General Anaesthesia: A Randomised Double BlindTrial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- First rescue analgesia
研究概览
简要总结
This randomized, double-blind, parallel-group, single-center trial compares the efficacy of ultrasound-guided erector spinae plane (ESP) block to local infiltration analgesia (LIA) with 0.25% Levobupivacaine in patients undergoing lumbar spine fixation surgery under general anesthesia. The primary outcome is the time to first rescue analgesia post-surgery. Secondary outcomes include hemodynamic parameters (mean arterial pressure and heart rate) at various intervals up to 24 hours post-surgery, postoperative pain scores using the Numerical Rating Scale (NRS), functional recovery (time to first ambulation and self-voiding), patient satisfaction for pain relief using a 5-point Likert scale, and postoperative nausea and vomiting (PONV) scores at 0.5, 1, 2, 6, 12, and 24 hours post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 or 2 level spine fixation surgeries Body mass index (BMI).
- •18-30 kg/m2 American Society of Anaesthesiology (ASA) Grade.
排除标准
- •Refusal of consent to participate in study More than 2 level of spine fixation surgery Coagulation disorders(INR more than 1.5) History of hypersensitivity to local or systemic anaesthetic agents Block Failure.
结局指标
主要结局
First rescue analgesia
时间窗: in postoperative period within 24 hours
次要结局
- Hemodynamic parameters, Postoperative pain scores, Functional recovery,(Patient satisfaction & PONV)