Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
Primary Purpose
Rotator Cuff Tear Arthropathy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy
Eligibility 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.
Sites / Locations
- UCSF Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Control
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Opiate consumption in patients prescribed ibuprofen versus placebo
pain control
Secondary Outcome Measures
Assessment of functional shoulder outcome score: ASES
Assessment of functional shoulder outcome score: DASH
Preop, 1 year post/op, 2 years post/op
Assessment of functional shoulder outcome score: SF-12
Post operative pain score (Visual Analog Scale)
pain
Range of Motion
Full Information
NCT ID
NCT02588027
First Posted
October 7, 2015
Last Updated
July 5, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02588027
Brief Title
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
Official Title
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Advil, Motrin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmacy formulated placebo
Primary Outcome Measure Information:
Title
Opiate consumption in patients prescribed ibuprofen versus placebo
Description
pain control
Time Frame
1 week post operative
Secondary Outcome Measure Information:
Title
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
Title
Assessment of functional shoulder outcome score: DASH
Description
Preop, 1 year post/op, 2 years post/op
Time Frame
2 years
Title
Assessment of functional shoulder outcome score: SF-12
Time Frame
Preop, 1 year post/op, 2 years post/op
Title
Post operative pain score (Visual Analog Scale)
Description
pain
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Benjamin Ma, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Orthopaedic Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15276196
Citation
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.
Results Reference
background
PubMed Identifier
23302898
Citation
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.
Results Reference
background
PubMed Identifier
2064886
Citation
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.
Results Reference
background
PubMed Identifier
15161166
Citation
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.
Results Reference
background
PubMed Identifier
16210573
Citation
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.
Results Reference
background
PubMed Identifier
25436192
Citation
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.
Results Reference
background
PubMed Identifier
19535272
Citation
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.
Results Reference
background
PubMed Identifier
23206691
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder
We'll reach out to this number within 24 hrs