The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

The University of Chicago

Status and phase: Withdrawn; Phase 4

Conditions: Rotator Cuff Tear

Treatments: Drug: Hydrocodone/Acetaminophen; Procedure: Rotator cuff repair; Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02153177

IRB 14-0540

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• rotator cuff tear
• age 45-75 years

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

NSAID and pain medication arm

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole

Procedure: Rotator cuff repair

pain medication arm

Active Comparator group

Description:

Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.

Treatment:

Procedure: Rotator cuff repair

Drug: Hydrocodone/Acetaminophen