The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

February 21, 2023 updated by: University of Chicago

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • rotator cuff tear
  • age 45-75 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Rotator cuff repair procedure
Drug: Hydrocodone/Acetaminophen
Hydrocodone/Acetaminophen is given for pain control after the surgery.
Other Names:
  • Norco

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Lewis L Shi, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 14-0540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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