The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

NCT ID: NCT02153177

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic procedure

Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole

Intervention Type DRUG

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.

pain medication arm

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

Group Type ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic procedure

Hydrocodone/Acetaminophen

Intervention Type DRUG

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

Interventions

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Rotator cuff repair

Arthroscopic procedure

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Hydrocodone/Acetaminophen

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

Intervention Type DRUG

Other Intervention Names

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Rotator cuff repair procedure Motrin, Advil (Ibuprofen) Norco (Hydrocodone/Acetaminophen) Prilosec (Omeprazole) Norco

Eligibility Criteria

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Inclusion Criteria

* rotator cuff tear
* age 45-75 years

Exclusion Criteria

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

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lewis L Shi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 14-0540

Identifier Type: -

Identifier Source: org_study_id

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