Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient reported pain level using a verbal numeric pain scale (NPS)
研究概览
简要总结
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to usual analgsic care.
详细描述
Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Controlling postoperative pain is a critical first step in facilitating a patient's recovery and improved quality of life. In-hospital pain levels will be measured using a numeric pain scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard of care protocol. Assessments are every four to six hours, within 60 minutes after receiving a pain medication
Hypothesis: Patients treated with the MMA pain protocol will have significantly less immediate postoperative pain as compared to patients treated with the standard pain protocol.
Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing narcotic consumption following lumbar spinal fusion surgery is important for faster recovery for the patient, decreasing narcotic related side effects (nausea and vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount of narcotic use during the course of the hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing a single level lumbar decompression and fusion
- •> 18 years of age and < 70 years of age
- •The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study
排除标准
- •Patients with liver disease (documented liver function test abnormality)
- •Patients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)
- •Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
- •Patients with active alcohol dependence
- •Patients with active illicit drug dependence
- •Patients < 18 years of age and >70 years of age
- •Patients allergic to any medication given in either arm (list medications)
- •Patients who have a seizure disorder
研究组 & 干预措施
Multimodal Analgesia (MMA) Treatment
干预措施: Multimodal Analgesia Treatment (Other)
Standard of Care Pain Managment Protocol
干预措施: Standard of Care Pain Management Protocol (Other)
结局指标
主要结局
Patient reported pain level using a verbal numeric pain scale (NPS)
时间窗: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
While in the hospital, patient's pain is assessed by a nurse-driven standard of care protocol. Assessments are typically every four to six hours or within 60 minutes after receiving an intravenous or oral analgesic medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
次要结局
- Length of stay(Hospital discharge (an expected average of 2 days after surgery))
- Patient satisfaction(In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days))
- Discharge destination(Hospital discharge (an expected average of 2 days after surgery))
- Oswestry Disability Index (ODI)(pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative)
- The Veterans Rand 12 (VR-12)(pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative)
- Narcotic consumption(In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days))