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

University of California, San Francisco110 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Rotator Cuff Tear Arthropathy

Interventions

IbuprofenDRUG

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.

PlaceboDRUG

Pharmacy formulated placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UCSF Orthopaedic Institute

San Francisco, California, United States

Outcomes

Primary Outcomes

Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo

pain control

Time frame: 1 week post operative

Secondary Outcomes

Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)

American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities).

Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

Assessment of Functional Shoulder Outcome Score: DASH

The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome

Time frame: preop, 1 year postop

Assessment of Functional Shoulder Outcome Score: SF-12

The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.

Time frame: Preop, 1 year post/op

Data from ClinicalTrials.gov

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