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

Not Applicable

Completed

Conditions: Rotator Cuff Tear Arthropathy

Interventions: Drug: Placebo
Drug: Ibuprofen

Registration Number: NCT02588027

Lead Sponsor: University of California, San Francisco

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Control	Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo	1 week post operative	pain control

Secondary Outcome Measures

Name	Time	Method
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)	Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op	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).
Assessment of Functional Shoulder Outcome Score: DASH	preop, 1 year postop	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
Assessment of Functional Shoulder Outcome Score: SF-12	Preop, 1 year post/op	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.
Post Operative Pain Score (Visual Analog Scale)	6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op	Pain scale from 0 (no pain) - 10 (worst)
Range of Motion - Forward Flexion	Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op	Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Range of Motion - Abduction	preoperative, 6 weeks, 3 months, 6 months, 1 year	Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Range of Motion - External Rotation at Side	preoperative, 6 weeks, 3 months, 6 months, 1 year	Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Range of Motion - External Rotation at 90 Degrees Abduction	preoperative, 6 weeks, 3 months, 6 months, 1 year	Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees