Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Pain, Postoperative; Osteoarthritis Thumb

Treatments: Drug: NSAID capsules; Drug: Opioid capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04676802

58972

Details and patient eligibility

About

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.

Enrollment: 121 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing trapeziectomy for thumb osteoarthritis

English proficient,

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups

NSAIDS

Experimental group

Description:

Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.

Treatment:

Drug: NSAID capsules

Opioids

Experimental group

Description:

Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.

Treatment:

Drug: Opioid capsule