Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS) pain scores
研究概览
简要总结
Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.
详细描述
The study is to include consecutive patients who undergo ACL repair by fellowship trained surgeons at a single institution with minimum 12 week follow up. All patients between the ages of 13-50 who are willing and able to provide informed consent will be included. Patients will be assessed preoperatively and then at 2 weeks, 6 weeks,12 weeks, and 1 year clinic visits, which is standard of care. The patient will fill out 2 questions on the MyCap app the day of surgery and for 14 days following surgery for pain scores and 15 days for amount of opioid pills consumed the day prior. Patient demographic, comorbidity, and surgical data will be collected from the medical record, including age, sex, BMI, smoking status, and diabetic status.
Patients will be randomized to the treatment or control group. The treatment group will receive the following pain regimen after surgery: Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin. The control group will be prescribed: Ketoralac, Hydrocodone/Acetaminophen, and Gabapentin. Pain reporting and opioid consumption will be assessed via the MyCap app for two weeks following surgery.
Patients will be followed at standard of care clinic appointments for 1 year. PROMs data will be collected at that time, in addition to any complications.
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
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing ACL repair or ACL reconstruction with tendon autograft
- •Age 13-50 years old
- •Able to provide informed consent or parent/legal guardian is able for minors
排除标准
- •Concurrent and significant injury to other bones or organs (Injury Severity Score of 4 or greater)
- •Revision ACL reconstruction
- •Concomitant additional ligament reconstruction or high tibial osteotomy
- •A history of alcohol abuse, substance abuse or chronic opioid use (filled opioid medication ×2 within 6 months of the surgery)
- •A history of renal failure (<60 mL/min/1.73 m2), liver dysfunction (child class, >B), severe heart disease (NYHA Class 4), diabetes, neurological or psychiatric diseases that may affect pain perception, and pre-existing immune suppression.
- •A history or active peptic ulcer disease, gastrointestinal bleeding, or current use of anticoagulation.
- •Patients currently taking oral or injectable glucocorticoids and those who have taken either within 1 month of the procedure.
- •Patients who are currently pregnant.
- •Patients who are unable to undergo the multimodal pain standardized protocol including those with comorbidities or medical allergies precluding the use of corticosteroids, gabapentin, hydrocodone, acetaminophen, ketorolac, and/or meloxicam.
研究组 & 干预措施
Medrol group
Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Meloxicam 15 mg (Drug)
Medrol group
Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Medrol 4 MG Oral Tablet Includes Medrol Dosepak (Drug)
Medrol group
Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Gabapentin 300 mg (Drug)
Medrol group
Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Hydrocodone 5Mg/Acetaminophen 325Mg Tab (Drug)
No Medrol group
Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Gabapentin 300 mg (Drug)
No Medrol group
Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Hydrocodone 5Mg/Acetaminophen 325Mg Tab (Drug)
No Medrol group
Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
干预措施: Ketorolac 10 Mg Oral Tablet (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) pain scores
时间窗: Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks
Zero is equivalent to no pain and 10 indicates the worst possible pain
次要结局
- Opioid consumption after surgery(0-14 days postoperative)
研究者
Scott Kaar, MD
Professor, Orthopaedic Surgery
St. Louis University