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The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153177
Recruitment Status : Withdrawn (The study was withdrawn prior to any participants being enrolled.)
First Posted : June 2, 2014
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Lewis L Shi, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02153177    
Other Study ID Numbers: IRB 14-0540
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
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:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Omeprazole
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
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