The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score
研究概览
简要总结
The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.
详细描述
Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rotator cuff tear
- •age 45-75 years
排除标准
- •pregnancy
- •chronic kidney disease
- •liver cirrhosis
- •hematologic malignancy
- •alcohol abusing
- •drug abusing
研究组 & 干预措施
NSAID and pain medication arm
After a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole.
干预措施: Rotator cuff repair (Procedure)
NSAID and pain medication arm
After a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole.
干预措施: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole (Drug)
pain medication arm
Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
干预措施: Rotator cuff repair (Procedure)
pain medication arm
Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
干预措施: Hydrocodone/Acetaminophen (Drug)
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
时间窗: one year
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
次要结局
- Ultrasound evaluation of retear rate(one year)