Pain, PostoperativePhase 4NCT04676802
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
A Phase 4 study testing NSAID capsules and Opioid capsule in people with Pain, Postoperative and Osteoarthritis Thumb, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pain, Postoperative, Osteoarthritis Thumb
- What is being tested?
- NSAID capsules and Opioid capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2021to 18 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing trapeziectomy for thumb osteoarthritis
- English proficient,
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Health Care
Redwood City, California, 94063
University of Utah Health Care
Salt Lake City, Utah, 84112-
About this study
Official title: Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
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.
- Conditions
- Pain, Postoperative, Osteoarthritis Thumb
- Being tested
- NSAID capsules, Opioid capsule
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAID capsulesDrug
1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage
Opioid capsuleDrug
1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
| Study group | Role | What they receive |
|---|---|---|
| NSAIDS | Experimental | Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys. Receives: Drug: NSAID capsules |
| Opioids | Experimental | Following surgery will receive opioid capsules following surgery. Will take online and phone surveys. Receives: Drug: Opioid capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of medication consumption and overall amount
The number of capsules consumed in the last 24 hours. Consumption rate and overall consumption will be compared between groups to assess efficacy and inform further statistical analyses.
Measured: Every day from the first day after surgery to 30 days post-op.
Change of worst daily pain score measured over time
Numerical score describing surgical pain at its worst in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Measured: Every day from the first day after surgery to 30 days post-op.
Change of least daily pain score measured over time
Numerical score describing surgical pain at its least in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Measured: Every day from the first day after surgery to 30 days post-op.
Change of average daily pain score measured over time
Numerical score describing average surgical pain in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Measured: Every day from the first day after surgery to 30 days post-op.
Secondary outcomes (2)
Change in Quick DASH scores over time
Quick Disabilities of the Arm, Shoulder, and Hand (qDASH) is a responsive measure to patient-reported functional change in the hand and upper extremity patient population, ranging from 0 to 100. Lower scores signify limited function and increased pain.
Measured: Baseline, Post-operative weeks 1, 3, 5, and 8
Change in PROMIS-PI scores over time
PROMIS-PI scores (Patient-Reported Outcomes Measurement Information System - Pain Interference) are effective measures of the change in perceived pain, supporting intervention related studies assessing power analyses for comparative research.
We use the Pain Interference - Short Form version 6b, which consists of 6 questions regarding how much the pain experienced in the last 7 days interfered with everyday aspects of life (i.e. enjoyment, ability to concentrate, day to day activities, recreational activities, doing tasks away from home, and socializing with others). The answers to all questions are ordinals ranging from 1 (not interfered at all) to 5 (interfered very much).
Measured: Baseline, Post-operative weeks 1, 3, 5, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start27 Dec 2021
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Why it stopped: Study drug supply unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Ladd, Stanford University
- Investigators
- Amy Ladd, MD, Principal investigator, Stanford Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676802
- Sponsor's protocol ID
- 58972
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
- ClinicalTrials.gov ID
- NCT04676802
- Acronym / sponsor ID
- 58972
- Conditions
- Pain, Postoperative, Osteoarthritis Thumb
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study drug supply unavailable
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAIDS | Experimental | Drug: NSAID capsulesFollowing surgery will receive NSAID capsules following surgery. Will take online and phone surveys. |
| Opioids | Experimental | Drug: Opioid capsuleFollowing surgery will receive opioid capsules following surgery. Will take online and phone surveys. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing trapeziectomy for thumb osteoarthritis
- English proficient,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAID capsules1, Ibuprofen 400-mg and 1, Acetaminophen 500-mg capsule per dosage | Drug | NSAIDS |
| Opioid capsule1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage | Drug | Opioids |
Primary outcome
Change of medication consumption and overall amount
Time frame: Every day from the first day after surgery to 30 days post-op.
The number of capsules consumed in the last 24 hours. Consumption rate and overall consumption will be compared between groups to assess efficacy and inform further statistical analyses.
Change of worst daily pain score measured over time
Time frame: Every day from the first day after surgery to 30 days post-op.
Numerical score describing surgical pain at its worst in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Change of least daily pain score measured over time
Time frame: Every day from the first day after surgery to 30 days post-op.
Numerical score describing surgical pain at its least in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Change of average daily pain score measured over time
Time frame: Every day from the first day after surgery to 30 days post-op.
Numerical score describing average surgical pain in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
2 secondary outcomes
Change in Quick DASH scores over time
Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8
Change in PROMIS-PI scores over time
Time frame: Baseline, Post-operative weeks 1, 3, 5, and 8
Results and safety
The study was stopped early (reason given: Study drug supply unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Ladd, MD principal investigator
Stanford Orthopaedic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NSAID capsules and Opioid capsule in people with Pain, Postoperative and Osteoarthritis Thumb, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study drug supply unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.