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Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder

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ClinicalTrials.gov Identifier: NCT02588027
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Ma, 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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Arthropathy Drug: Ibuprofen Drug: Placebo Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
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
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.
Other Names:
  • Advil
  • Motrin

Placebo Comparator: 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.
Drug: Placebo
Pharmacy formulated placebo




Primary Outcome Measures :
  1. Opiate consumption in patients prescribed ibuprofen versus placebo [ Time Frame: 1 week post operative ]
    pain control


Secondary Outcome Measures :
  1. Assessment of functional shoulder outcome score: ASES [ Time Frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op ]
  2. Assessment of functional shoulder outcome score: DASH [ Time Frame: 2 years ]
    Preop, 1 year post/op, 2 years post/op

  3. Assessment of functional shoulder outcome score: SF-12 [ Time Frame: Preop, 1 year post/op, 2 years post/op ]
  4. Post operative pain score (Visual Analog Scale) [ Time Frame: 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 ]
    pain

  5. Range of Motion [ Time Frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588027


Contacts
Contact: C. Benjamin Ma, MD Maben@ucsf.edu

Locations
United States, California
UCSF Orthopaedic Institute Recruiting
San Francisco, California, United States, 94143
Contact    415-514-6120      
Principal Investigator: Chunbong B Ma, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: C. Benjamin Ma, MD University of California, San Francisco

Publications:

Responsible Party: Benjamin Ma, Professor in Residence, Chief of Sports Medicine and Shoulder Service, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02588027     History of Changes
Other Study ID Numbers: 15-16665
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Rotator Cuff Injuries
Joint Diseases
Rotator Cuff Tear Arthropathy
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Musculoskeletal Diseases
Chondrocalcinosis
Arthritis
Crystal Arthropathies
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Opiate Alkaloids
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid