Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Usage of Opioids for Pain Control
研究概览
简要总结
The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.
详细描述
Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
- •between the ages of 18 and 65 years old
排除标准
- •chronic pre-operative narcotic pain medication use
- •undergoing superior capsular reconstruction / balloon interposition etc
- •< 18 y/o or > 65 y/o
- •bilateral rotator cuff tear
- •currently taking prescribed sleep-aid medications
- •history of fibromyalgia or chronic pain syndrome
- •pain management patient
- •narcolepsy diagnosis
- •diagnosis of cervical radiculopathy
- •reported non-shoulder pain interfering with sleep
研究组 & 干预措施
Control
Patients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.
干预措施: Placebo (Drug)
Gabapentin
Patients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Usage of Opioids for Pain Control
时间窗: Up to 12 weeks postoperatively
Determined based on morphine milligram equivalents
Change in Sleep Quality
时间窗: Up to 12 weeks postoperatively
Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep)
次要结局
- Change in Functional Outcome (Based on Survey)(Up to 12 weeks postoperatively)
- Change in Pain(Up to 12 weeks postoperatively)
- Change in Functional Outcome (Based on Prior Baseline)(Up to 12 weeks postoperatively)