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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Rotator Cuff Tear Arthropathy

Treatments: Drug: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02588027

15-16665

Details and patient eligibility

About

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.

Full 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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo