Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The study aims to study the effect of intraoperative epidural application of anesthetic cocktail following endoscopic lumbar discectomy in improving postoperative pain, length of hospital stay, time at first dose analgesia, post-operative opioid consumption, functional outcomes, time return to work, and postoperative complications
详细描述
This is a randomized controlled trial study the effects of epidural anesthetic cocktail. The cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope. 54 participants are deivided into two arms, experimental and placebo group, and randomized into the trial. Primary objective is the ODI score from patient-reported function outcome at 3 months with secondary objective as mentioned above.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •Lumbar radiculopathy
- •No prior spinal surgery or recurrent lumbar disc herniation
- •Plan for endoscopic discectomy after failed conservative for at least 6 weeks
- •Single-level herniation confirmed by MRI which correlated with symptoms
排除标准
- •Allergic or contraindicated to amide-type anesthesia, opioid, NSAIDs, or steroids
- •Cauda equina syndrome
- •Concomitant with other abnormalities
- •Unable to answer questionnaires
- •Cannot tolerate surgery due to medical comorbidities
研究组 & 干预措施
Epidural Anesthetic Cocktail
Patients which received epidural anesthetic cocktail following endoscopic discectomy
干预措施: Epidural Anesthetic Cocktail (Drug)
Placebo
Patients which received placebo following endoscopic discectomy
干预措施: Placebo (Drug)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 3rd month
To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months
次要结局
- Functional Outcomes(POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr)
- Postoperative outcomes(POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr)