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

NCT02588027 | Completed Results

• 1 other identifier: 15-16665
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

• Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo

  pain control

  1 week post operative

Secondary Outcomes (8)

• 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

• Assessment of Functional Shoulder Outcome Score: DASH

  preop, 1 year postop

• Assessment of Functional Shoulder Outcome Score: SF-12

  Preop, 1 year post/op

• Post Operative Pain Score (Visual Analog Scale)

  6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

• Range of Motion - Forward Flexion

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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Ibuprofen DRUG

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.

Also known as: Advil, Motrin

Control

Placebo DRUG

Pharmacy formulated placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Patients that undergo arthroscopic rotator cuff repair only

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Orthopaedic Institute

San Francisco, California, 94143, United States

Location

Related Publications (8)

• Gilson AM, Ryan KM, Joranson DE, Dahl JL. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002. J Pain Symptom Manage. 2004 Aug;28(2):176-88. doi: 10.1016/j.jpainsymman.2004.01.003.

  PMID: 15276196 BACKGROUND

• Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.

  PMID: 23302898 BACKGROUND

• Dahl JB, Kehlet H. Non-steroidal anti-inflammatory drugs: rationale for use in severe postoperative pain. Br J Anaesth. 1991 Jun;66(6):703-12. doi: 10.1093/bja/66.6.703. No abstract available.

  PMID: 2064886 BACKGROUND

• Dahners LE, Mullis BH. Effects of nonsteroidal anti-inflammatory drugs on bone formation and soft-tissue healing. J Am Acad Orthop Surg. 2004 May-Jun;12(3):139-43. doi: 10.5435/00124635-200405000-00001.

  PMID: 15161166 BACKGROUND

• Cohen DB, Kawamura S, Ehteshami JR, Rodeo SA. Indomethacin and celecoxib impair rotator cuff tendon-to-bone healing. Am J Sports Med. 2006 Mar;34(3):362-9. doi: 10.1177/0363546505280428. Epub 2005 Oct 6.

  PMID: 16210573 BACKGROUND

• Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10.

  PMID: 25436192 BACKGROUND

• Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.

  PMID: 19535272 BACKGROUND

• van der Zwaal P, Thomassen BJ, Nieuwenhuijse MJ, Lindenburg R, Swen JW, van Arkel ER. Clinical outcome in all-arthroscopic versus mini-open rotator cuff repair in small to medium-sized tears: a randomized controlled trial in 100 patients with 1-year follow-up. Arthroscopy. 2013 Feb;29(2):266-73. doi: 10.1016/j.arthro.2012.08.022. Epub 2012 Dec 1.

  PMID: 23206691 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Jennifer Tangtiphaiboontana
• Organization: University of California, San Francisco

Jennifer.Tangtiphaiboontana@ucsf.edu

5622095440

Study Officials

• C. Benjamin Ma, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Locations

US (1)