RecruitingPhase 2NCT04676802

Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone


Sponsor

Stanford University

Enrollment

121 participants

Start Date

Dec 27, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.


Eligibility

Min Age: 45 Years

Inclusion Criteria2

  • Undergoing trapeziectomy for thumb osteoarthritis
  • English proficient,

Exclusion Criteria8

  • Pregnancy
  • Current use of opioids
  • Concurrent surgeries (ex. trapeziectomy combined with carpal tunnel release)
  • Inability to complete study forms (education, cognitive ability, mental status, medical status)
  • Allergy or intolerance to Ibuprofen, Acetaminophen and/or Oxycodone
  • Liver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen
  • History of chronic heart failure, upper gastrointestinal bleeding or coagulopathy
  • History of complex regional pain syndrome

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Interventions

DRUGNSAID capsules

1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage

DRUGOpioid capsule

1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage


Locations(2)

Stanford Health Care

Redwood City, California, United States

University of Utah Health Care

Salt Lake City, Utah, United States

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NCT04676802


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