Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cumulative Morphine Milligrams at 72 hours post-operative
研究概览
简要总结
Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion
详细描述
This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.
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)
盲法说明
Placebo, randomization and blinding will be maintained by the Hospital Pharmacy
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years old
- •Patients undergoing 1 to 3 level posterolateral fusion
- •Opioid naïve or not
- •No prior spine fusion
- •Willing and able to sign an Informed Consent
排除标准
- •Indication for surgery is fracture, tumor or infection
- •Comorbid psychiatric diagnosis requiring therapy and/or medication
- •Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)
- •Has hepatic disease
- •On workers compensation/disability/litigation
- •Known adverse reaction to medications to be administered
- •History of alcohol and drug abuse
- •On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)
研究组 & 干预措施
Dronabinol
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
干预措施: Dronabinol 2.5mg Cap (Drug)
Placebo
Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Morphine Milligrams at 72 hours post-operative
时间窗: 72 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
次要结局
- Cumulative Morphine Milligrams at 24 hours post-operative(24 hours post-operative)
- Cumulative Morphine Milligrams at 48 hours post-operative(48 hours post-operative)
- Worst pain in past 24 hours post-operative(24 hours post-operative)
- Worst pain in past 72 hours post-operative(72 hours post-operative)
- Worst pain in past 48 hours post-operative(48 hours post-operative)
研究者
Jeffrey L Gum MD
Attending Spine Surgeon
Norton Leatherman Spine Center