NCT02588027

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes After Arthroscopic Rotator Cuff Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be randomized into two cohorts: 1. Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. 2. Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria. Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery

Conditions

• Rotator Cuff Tear Arthropathy

Interventions

Type	Name	Description
DRUG	Ibuprofen	Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.
DRUG	Placebo	Pharmacy formulated placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2015-10-27
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: United States