The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

Phase 4

Withdrawn

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Rotator cuff repair; Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole; Drug: Hydrocodone/Acetaminophen

• Registration Number: NCT02153177
• Lead Sponsor: 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-02
• Study Start: 2015-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• rotator cuff tear
• age 45-75 years

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAID and pain medication arm	Rotator cuff repair	After a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole.
NSAID and pain medication arm	Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole	After 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 arm	Rotator cuff repair	Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
pain medication arm	Hydrocodone/Acetaminophen	Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	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

Name	Time	Method
Ultrasound evaluation of retear rate	one year	Ultrasound evaluation of retear rate at 6 months after the procedure

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States