Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder

Study Overview
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Brief Summary
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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
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Patients will be randomized into two cohorts: 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. 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

Official Title
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Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder

Conditions
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Rotator Cuff Tear Arthropathy

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Drug: Ibuprofen<br>* 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.<br>* Other names: Motrin;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Pharmacy formulated placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption in patients prescribed ibuprofen versus placebo | pain control | 1 week post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of functional shoulder outcome score: ASES |  | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op | 
| Assessment of functional shoulder outcome score: DASH | Preop, 1 year post/op, 2 years post/op | 2 years | 
| Assessment of functional shoulder outcome score: SF-12 |  | Preop, 1 year post/op, 2 years post/op | 
| Post operative pain score (Visual Analog Scale) | pain | Preop, 1 week post/op, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op | 
| Range of Motion |  | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op |