N/A
N=110
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes
Rotator Cuff Tear Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT02588027 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo — 168.3; 210.9 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ibuprofen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo |
168.3; 210.9 | — |
| SECONDARY Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) |
57.8; 56.2; 54.6; 54; 69.4; 69.3 | — |
| SECONDARY Assessment of Functional Shoulder Outcome Score: DASH |
62.6; 62.3; 31.9; 36.4 | — |
| SECONDARY Assessment of Functional Shoulder Outcome Score: SF-12 |
42.3; 40.3; 52.5; 49.4; 51.2; 50.1 | — |
| SECONDARY Post Operative Pain Score (Visual Analog Scale) |
2.1; 2.5; 1.8; 1.8; 0.9; 1.3 | — |
| SECONDARY Range of Motion - Forward Flexion |
137; 133; 92; 96; 142; 138 | — |
| SECONDARY Range of Motion - Abduction |
133; 125.2; 73; 76.7; 131; 132.8 | — |
| SECONDARY Range of Motion - External Rotation at Side |
58; 59.7; 35; 36; 51; 56 | — |
| SECONDARY Range of Motion - External Rotation at 90 Degrees Abduction |
68; 68; 42; 42; 69; 68 | — |
Summary
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years or older
- Patients that undergo arthroscopic rotator cuff repair only
Exclusion Criteria
- Patients less than 18 years of age, pregnant, are incarcerated. Women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our UCSF Orthopaedic Institute preoperative guidelines.
- Patients who are unable to and not willing to comply with the study protocol and follow-up visits
- Patients with a history of prior rotator cuff repair
- Patients with rotator cuff tears that require open repair
- Patients with an allergy to ibuprofen or anti-inflammatory medications
- Patients with a medical chart record or those who report a history of upper gastroenterology bleed or gastric ulcers
- Patients who are currently on warfarin, enoxaparin, heparin, or a factor Xa inhibiting anti-coagulation medication
- Patients with a known past medical history of chronic kidney disease, history of kidney transplant, or eGFR < 60 mL/min per 1.73m2.
Data sourced from ClinicalTrials.gov (NCT02588027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.