Nonopioid Analgesia After Rotator Cuff Repair

Study Overview
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Brief Summary
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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

Detailed Description
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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 visual analogue scale and Patient-Reported Outcomes Measurement Information System. 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.

Official Title
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Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Ketorolac
* Drug: Gabapentin
* Drug: Acetaminophen
* Drug: Diazepam
* Drug: Hydrocodone-Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-Operative Non Opioid Pain Protocol<br>Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam | Drug: Celecoxib<br>* Post-Operative Non Opioid Pain Protocol<br>* Other names: Celebrex;Drug: Ketorolac<br>* Post-Operative Non Opioid Pain Protocol<br>* Other names: Tylenol;Drug: Gabapentin<br>* Post-Operative Non Opioid Pain Protocol<br>* Other names: Neurontin;Drug: Acetaminophen<br>* Post-Operative Non Opioid Pain Protocol<br>* Other names: Tylenol;Drug: Diazepam<br>* Post-Operative Non Opioid Pain Protocol<br>* Other names: Valium;|
| Active Comparator: Post-Operative Traditional Pain Protocol<br>Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500 | Drug: Hydrocodone-Acetaminophen<br>* Traditionally used narcotic pain protocol<br>* Other names: Norco;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Levels | Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control. | 10 days post-operatively | 
| Patient-Reported Outcomes Measurement Information System | Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) once every night for 10 days post-operatively. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference. | 10 days post-operatively |