Traditional vs. Nonopioid Analgesia After Labral Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System
研究概览
简要总结
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
详细描述
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis
All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult patients over age 18 and scheduled for a primary or revision labral surgery
排除标准
- •Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
研究组 & 干预措施
Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
干预措施: Celecoxib (Drug)
Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
干预措施: Ketorolac (Drug)
Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
干预措施: Gabapentin (Drug)
Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
干预措施: Acetaminophen (Drug)
Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
干预措施: Diazepam (Drug)
Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325
干预措施: Hydrocodone-Acetaminophen (Drug)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System
时间窗: 10 days post-operatively
Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
Pain Levels
时间窗: 10 days post-operatively
Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.
次要结局
未报告次要终点
研究者
Toufic R. Jildeh
Resident Investigator
Henry Ford Health System