Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.
详细描述
This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.
Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full thickness rotator cuff tear
- •Pre operative MRI
- •Patients who are medically stable to undergo the surgery
- •Patients who consent to involvement in the study
排除标准
- •Prior surgery on the involved shoulder
- •Preoperative MRI suggesting that the rotator cuff tear is unrepairable
- •Patients with known allergies to oxycodone, bupivacaine or a similar drug
- •Workman's compensation patients
- •Patients who do not fill out their visual analog scores or their medication diaries.
研究组 & 干预措施
Placebo group
The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
干预措施: Normal Saline (Drug)
Study Group
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
干预措施: 0.5% bupivacaine (Drug)
结局指标
主要结局
Pain Scores
时间窗: O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.
Pain was measured via Visual Analong Scale in measurement (0-100mm).
次要结局
未报告次要终点
研究者
Paula J. Harriott
Orthopedic surgeon, Orlando Orthopaedic Center
Orlando Health, Inc.