The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Post-operative narcotics usage
研究概览
简要总结
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
详细描述
The purpose of this study is to investigate whether a previously described multimodal pain protocol involving non-narcotic medications compared to the medical center's current postoperative pain regimen mainly involving narcotics will decrease total rescue narcotics used for patients who undergo arthroscopic rotator cuff tear repair at Montefiore. The implications of the study would be reduced narcotics consumptions in postoperative patients and improved self-reported patient outcomes. Through this study, the investigator team hopes to develop a pain regimen that alleviates dependence on opioids in postoperative patients without sacrificing patient satisfaction and comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adults with rotator cuff tears who have failed conservative therapy and are now undergoing arthroscopic rotator cuff repair.
排除标准
- •Patients without capacity to consent for the study
- •Patients not able to have local nerve block
- •Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair
- •Patients who are unable to record and verbalize their pain level due to altered mental status
- •Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication
- •Patients with history of previously diagnosed alcohol or drug abuse, renal impairment, peptic ulcer disease, and gastrointestinal bleeding
- •Patients who are pregnant
研究组 & 干预措施
Standard Pain Regimen Group
Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.
干预措施: Standard of Care Pain Regimen (Drug)
Multimodal Pain Regimen Group
Multimodal pain regimen medications will be prescribed and administered preoperatively in preoperative holding area, intraoperatively during the procedure, and postoperatively as described in the Intervention Description.
干预措施: Multimodal Pain Regimen (Drug)
结局指标
主要结局
Post-operative narcotics usage
时间窗: Post-operative day 7
Post-operative narcotics usage will be assessed by the number of oxycodone tablets used in the first week (7 days) after surgery. The week's use will be accounted by counting the left-over oxycodone tablets brought in by the patients. In addition, the electronic medical record will be checked to ensure that no extra narcotics were called in. Results will be summarized by study arm using means and standard deviations.
Pain Score using the Visual Analogue Scale (VAS)
时间窗: Post-operative day 7
A pain score will be determined using the VAS, a unidimensional measure of pain intensity. Patients will be asked to rate and record pain intensity daily during the study. The VAS score at post-operative day 7 will be reported. The VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100, such that higher scores are indicative of greater pain intensity. Results will be summarized by study arm using basic descriptive statistics.
次要结局
未报告次要终点