The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

Study Overview
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Brief Summary
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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.

Detailed Description
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Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.

Official Title
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The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Rotator cuff repair
* Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole
* Drug: Hydrocodone/Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rotator cuff tear age 45-75 years Exclusion Criteria: diabetes pregnancy chronic kidney disease liver cirrhosis hematologic malignancy alcohol abusing drug abusing

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSAID and pain medication arm<br>After a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole. | Procedure: Rotator cuff repair<br>* Arthroscopic procedure<br>* Other names: Rotator cuff repair procedure;Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole<br>* In addition to pain medication after the procedure patients will receive Ibuprofen and Omeprazole. Omeprazole is given to minimize the gastrointestinal side effects of Ibuprofen.<br>* Other names: Prilosec (Omeprazole);|
| Active Comparator: pain medication arm<br>Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure. | Procedure: Rotator cuff repair<br>* Arthroscopic procedure<br>* Other names: Rotator cuff repair procedure;Drug: Hydrocodone/Acetaminophen<br>* Hydrocodone/Acetaminophen is given for pain control after the surgery.<br>* Other names: Norco;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound evaluation of retear rate | Ultrasound evaluation of retear rate at 6 months after the procedure | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair