Back to resultsThe Effect of NSAIDs After a Rotator Cuff Repair Surgery.
Primary Purpose
Rotator Cuff Tear
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rotator cuff repair
Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole
Hydrocodone/Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair
Eligibility Criteria
Inclusion Criteria:
- rotator cuff tear
- age 45-75 years
Exclusion Criteria:
- diabetes
- pregnancy
- chronic kidney disease
- liver cirrhosis
- hematologic malignancy
- alcohol abusing
- drug abusing
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NSAID and pain medication arm
pain medication arm
Arm 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.
Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Secondary Outcome Measures
Ultrasound evaluation of retear rate
Ultrasound evaluation of retear rate at 6 months after the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02153177
Brief Title
The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
Official Title
The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn prior to any participants being enrolled.
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSAID and pain medication arm
Arm Type
Active Comparator
Arm 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.
Arm Title
pain medication arm
Arm Type
Active Comparator
Arm Description
Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure.
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair
Other Intervention Name(s)
Rotator cuff repair procedure
Intervention Description
Arthroscopic procedure
Intervention Type
Drug
Intervention Name(s)
Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole
Other Intervention Name(s)
Motrin, Advil (Ibuprofen), Norco (Hydrocodone/Acetaminophen), Prilosec (Omeprazole)
Intervention Description
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
Intervention Name(s)
Hydrocodone/Acetaminophen
Other Intervention Name(s)
Norco
Intervention Description
Hydrocodone/Acetaminophen is given for pain control after the surgery.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Description
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Ultrasound evaluation of retear rate
Description
Ultrasound evaluation of retear rate at 6 months after the procedure
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
rotator cuff tear
age 45-75 years
Exclusion Criteria:
diabetes
pregnancy
chronic kidney disease
liver cirrhosis
hematologic malignancy
alcohol abusing
drug abusing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis L Shi, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
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