CTRI/2024/05/067111尚未招募4 期
Effect of erector spinae plane block on quality of recovery in patients undergoing lumbar spine surgery.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Quality of Recovery-15 (QoR-15).
研究概览
简要总结
We are comparing the Quality of recovery with ultrasound guided Erector Spinae Plane Block with standard analgesia protocol and Local anaesthetic infiltration with standard analgesia protocol in patients 18-65 years of age undergoing lumbar spine surgery. The aim of study is to evaluate the effect of erector spinae plane block on quality of post operative recovery characteristics in patients undergoing lumbar spine surgery with a total sample size of 66 patients with 33 sample in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •American Society of Anesthesiologist (ASA) physical status I,II & III Expected surgical duration 2-4 hours.
排除标准
- •Surgical intervention for more than 2 vertebral levels.
- •Body Mass Index (BMI) 35kg/m
- •Pregnant patients.
- •Patients with known allergies to local anaesthestic drugs.
- •Patients with use of psychoactive substance.
- •Patients with chronic pain unrelated to surgical indication.
- •Contraindication to nerve block like coagulopathy and local site infections.
结局指标
主要结局
Quality of Recovery-15 (QoR-15).
时间窗: 24 hour after surgery.
次要结局
- QoR-15 score(48 hours after surgery and at the time of discharge.)
- Numeric rating scale (NRS) scores (at rest and at movement)(6,24,48 hours of surgery.)
- Mean time to first rescue analgesia(After surgery.)
- Total analgesic consumption.(At the end of 24 hours after surgery.)
- PONV impact scale score(6,24,48 hours after surgery.)
- Mean time to passing of flatus(After surgery.)
- Mean time ambulate with assistance.(After surgery.)
- Post Operative Sleep Quality Index (PSQI).(24,48 hours after surgery.)
研究者
Asaad Ahmad
Maulana Azad Medical College.
研究点 (1)
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