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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

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.

Details

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

Keywords

Rotator Cuff Tear Arthropathy Rotator Cuff Injuries Joint Diseases Acetaminophen Ibuprofen Acetaminophen, hydrocodone drug combination Opiate Alkaloids Hydrocodone Oxycodone

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients 18 years or older
  • Patients that undergo arthroscopic rotator cuff repair only

You CAN'T join if...

  • 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 gastic 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.

Location

  • UCSF Orthopaedic Institute accepting new patients
    San Francisco, California, 94143, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02588027
Lead Scientist
C. Benjamin Ma
Study Type
Interventional
Last Updated
October 2016
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