The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Primary Outcome - Worst NRS With Movement
研究概览
简要总结
Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids. The specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. This is a 'before and after' study. We plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. Both groups will receive identical postoperative follow-up.
详细描述
Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as inpatient and patients had availability of intravenous opioids. Assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, SD 2.1 (Kahn) which is often categorized as "severe" pain. Given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. With outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. Therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. Given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. This study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory rotator cuff patients with participating surgeons.
- •Includes the following concomitant procedures:
- •Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair
- •Arthroscopic Stabilization
- •Arthroscopic AC (Acromioclavicular) resection
- •Arthroscopic SAD (Sub-Acromial Decompression)
- •Arthroscopic or mini open biceps tenodesis
- •Age 18-80
排除标准
- •chronic pain history (defined as use of opioids > 3 months or current gabapentinoids for pain)
- •open surgery (but sub pectoralis mini open biceps tenodesis is not excluded)
- •revision surgery
- •kidney disease (GFR < 60 ml/min/1.73 m2 for 3 months or more)
- •liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy)
- •planned avoidance of regional anesthesia
- •any contraindication to or patient refusal of any component in the pathway
- •Non-English speakers
结局指标
主要结局
Primary Outcome - Worst NRS With Movement
时间窗: 0-48 hours after block placement
worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.
次要结局
- Block Duration(Through Post Op Day 2)
- Total Opioid Use(Post Op Days 1,2,7,14)
- Patient Satisfaction With Pain Management(Post Op Days 1,2,7,14)
- Pain Score at Rest(Post Op Days 1,2,7,14)