Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02588027
• Other study ID #: 15-16665
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

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.
• Placebo
Pharmacy formulated placebo

Locations

Country	Name	City	State
United States	UCSF Orthopaedic Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Epub 2005 Oct 6. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate consumption in patients prescribed ibuprofen versus placebo	pain control	1 week post operative
Secondary	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
Secondary	Assessment of functional shoulder outcome score: DASH	Preop, 1 year post/op, 2 years post/op	2 years
Secondary	Assessment of functional shoulder outcome score: SF-12		Preop, 1 year post/op, 2 years post/op
Secondary	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
Secondary	Range of Motion		Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op, 2 years post/op