Clinical trial NCT02588027: Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes
Official title: Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes After Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Primary outcomes:
measure: Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo
timeFrame: 1 week post operative
Secondary outcomes:
measure: Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)
timeFrame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
measure: Assessment of Functional Shoulder Outcome Score: DASH
timeFrame: preop, 1 year postop
measure: Assessment of Functional Shoulder Outcome Score: SF-12
timeFrame: Preop, 1 year post/op
measure: Post Operative Pain Score (Visual Analog Scale)
timeFrame: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
measure: Range of Motion - Forward Flexion
timeFrame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
measure: Range of Motion - Abduction
timeFrame: preoperative, 6 weeks, 3 months, 6 months, 1 year
measure: Range of Motion - External Rotation at Side
timeFrame: preoperative, 6 weeks, 3 months, 6 months, 1 year
measure: Range of Motion - External Rotation at 90 Degrees Abduction
timeFrame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopaedic Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: C. Benjamin Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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