Not provided
Not provided
Not provided
Not provided
Not provided
The study was withdrawn prior to any participants being enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID and pain medication arm | Active Comparator | 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 | Active Comparator | Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotator cuff repair | Procedure | Arthroscopic procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound evaluation of retear rate | Ultrasound evaluation of retear rate at 6 months after the procedure | one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lewis L Shi, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
Not provided
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D006853 | Hydrocodone |
| D000082 | Acetaminophen |
| D009853 | Omeprazole |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole | 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. |
|
|
| Hydrocodone/Acetaminophen | Drug | Hydrocodone/Acetaminophen is given for pain control after the surgery. |
|
|
| D003061 |
| Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |