Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT04676802
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis Thumb
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NSAID capsules — DRUG
    1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
  • Opioid capsule — DRUG
    1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage

Study Details

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.

Key Dates

Start date
Dec 27, 2021
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NSAIDS
    Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.
  • Experimental: Opioids
    Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.

Primary Outcome Measure

Change of medication consumption and overall amount [ Time Frame: Every day from the first day after surgery to 30 days post-op. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Health CareRedwood CityCalifornia94063
Deborah Kenney, MS OTR
[email protected]
(650) 721-7644
Amy Ladd, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Health CareSalt Lake CityUtah84112-
Mario Quesada, PS
[email protected]
Angela Wang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Redwood City, CA

By research site
Stanford Health Care· Redwood City, CAUniversity of Utah Health Care· Salt Lake City, UT

Related Studies