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The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02153177
Enrollment
0
Registered
2014-06-02
Start date
2015-01-31
Completion date
2018-12-31
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair

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.

Interventions

PROCEDURERotator cuff repair

Arthroscopic procedure

DRUGIbuprofen, 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.

Hydrocodone/Acetaminophen is given for pain control after the surgery.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* rotator cuff tear * age 45-75 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
American Shoulder and Elbow Surgeons (ASES) Shoulder Scoreone yearThe scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.

Secondary

MeasureTime frameDescription
Ultrasound evaluation of retear rateone yearUltrasound evaluation of retear rate at 6 months after the procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026