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The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

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ClinicalTrials.gov Identifier: NCT02153177
Recruitment Status : Suspended
First Posted : June 2, 2014
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Rotator cuff repair Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole Drug: Hydrocodone/Acetaminophen Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NSAID and pain medication arm
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
Arthroscopic procedure
Other Name: Rotator cuff repair procedure

Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole
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.
Other Names:
  • Motrin, Advil (Ibuprofen)
  • Norco (Hydrocodone/Acetaminophen)
  • Prilosec (Omeprazole)

Active Comparator: pain medication arm
Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
Procedure: Rotator cuff repair
Arthroscopic procedure
Other Name: Rotator cuff repair procedure

Drug: Hydrocodone/Acetaminophen
Hydrocodone/Acetaminophen is given for pain control after the surgery.
Other Name: Norco




Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: one year ]
    The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.


Secondary Outcome Measures :
  1. Ultrasound evaluation of retear rate [ Time Frame: one year ]
    Ultrasound evaluation of retear rate at 6 months after the procedure



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rotator cuff tear
  • age 45-75 years

Exclusion Criteria:

  • diabetes
  • pregnancy
  • chronic kidney disease
  • liver cirrhosis
  • hematologic malignancy
  • alcohol abusing
  • drug abusing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153177


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Lewis L Shi, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02153177     History of Changes
Other Study ID Numbers: IRB 14-0540
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by University of Chicago:
Randomized Controlled Trial (RCT)
RCT
rotator cuff tear
NSAIDs
non-steroidal anti-inflammatory drugs
rotator cuff repair

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Hydrocodone
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Acetaminophen
Ibuprofen
Analgesics
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents