Rotator Cuff Tear | The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
Rotator Cuff Tear research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - rotator cuff tear - age 45-75 years Exclusion Criteria: - diabetes - pregnancy - chronic kidney disease - liver cirrhosis - hematologic malignancy - alcohol abusing - drug abusing
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Rotator Cuff Tear
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Rotator cuff repairArthroscopic procedure
Drug:Ibuprofen, Hydrocodone/Acetaminophen, OmeprazoleIn addition to pain medication after the procedure patients will receive Ibuprofen and Omeprazole. Omeprazole is given to minimize the gastrointestinal side effects of Ibuprofen.
Drug:Hydrocodone/AcetaminophenHydrocodone/Acetaminophen is given for pain control after the surgery.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
NSAID and pain medication armAfter a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole.
pain medication armPatients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
Start Date: January 2015
Phase: Phase 4
Primary Outcome: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Secondary Outcome: Ultrasound evaluation of retear rate
Study sponsors, principal investigator, and references
Principal Investigator: Lewis L Shi, MD
Lead Sponsor: University of Chicago