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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Recruitment Status : Withdrawn (The study was withdrawn prior to any participants being enrolled.)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

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date February 23, 2023
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)		 Ultrasound evaluation of retear rate [ Time Frame: one year ]
Ultrasound evaluation of retear rate at 6 months after the procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
Official Title  ICMJE The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • 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)
  • Drug: Hydrocodone/Acetaminophen
    Hydrocodone/Acetaminophen is given for pain control after the surgery.
    Other Name: Norco
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Rotator cuff repair
    • Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole
  • Active Comparator: pain medication arm
    Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
    Interventions:
    • Procedure: Rotator cuff repair
    • Drug: Hydrocodone/Acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 21, 2023)		 0
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)		 60
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • rotator cuff tear
  • age 45-75 years

Exclusion Criteria:

  • diabetes
  • pregnancy
  • chronic kidney disease
  • liver cirrhosis
  • hematologic malignancy
  • alcohol abusing
  • drug abusing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153177
Other Study ID Numbers  ICMJE IRB 14-0540
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lewis L Shi, MD University of Chicago
PRS Account University of Chicago
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP