Carpometacarpal OsteoarthritisPhase 4NCT05556356
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
A Phase 4 study testing Acetaminophen in people with Carpometacarpal Osteoarthritis, run by Indiana Hand to Shoulder Center at 1 site in United States.
Trial summary
Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpometacarpal Osteoarthritis
- What is being tested?
- Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 6 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years of age or older)
- Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
- Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
- Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
- Bilateral thumbs included
Who cannot join
- <18 years age
- Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
- Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
- History of opioid dependency or current chronic opioid use
- Contraindication to acetaminophen use
- Contraindication to NSAID use
Show all 10Show fewer
- Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
- Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
- Contraindication to multivitamin use
- Liver dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
About this study
Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.
- Conditions
- Carpometacarpal Osteoarthritis
- Being tested
- Acetaminophen, Placebo: Multivitamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
pre-operative acetaminophen (1000mg)
Placebo: MultivitaminOther
pre-operative Multivitamin
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Preoperative multivitamin and postoperative standardized pain management regimen Receives: Other: Placebo: Multivitamin |
| Test Group | Experimental | : Preoperative acetaminophen and postoperative standardized pain management regimen Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Measured: 2 weeks
Number of Narcotic Pills Used
Number of Narcotic Pills Used
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start13 Sep 2022
- Primary completion6 May 2024
- Study completion6 May 2024
Why it stopped: Physician decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpometacarpal OsteoarthritisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Hand to Shoulder Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556356
- Sponsor's protocol ID
- IU15386
- Status last verified
- Oct 2024
- First submitted
- 22 Sep 2022
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
- ClinicalTrials.gov ID
- NCT05556356
- Acronym / sponsor ID
- IU15386
- Conditions
- Carpometacarpal Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Physician decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Indiana Hand to Shoulder CenterUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 27 Sep 2022 (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.
Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Placebo: MultivitaminPreoperative multivitamin and postoperative standardized pain management regimen |
| Test Group | Experimental | Drug: Acetaminophen: Preoperative acetaminophen and postoperative standardized pain management regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years of age or older)
- Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
- Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
- Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
- Bilateral thumbs included
Key exclusion criteria (10 listed)
- <18 years age
- Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
- Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
- History of opioid dependency or current chronic opioid use
- Contraindication to acetaminophen use
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 |
|---|---|---|
| AcetaminophenAlso: Tylenolpre-operative acetaminophen (1000mg) | Drug | Test Group |
| Placebo: Multivitaminpre-operative Multivitamin | Other | Control Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 2 weeks
Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Number of Narcotic Pills Used
Time frame: 2 weeks
Number of Narcotic Pills Used
Results and safety
The study was stopped early (reason given: Physician decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen in people with Carpometacarpal Osteoarthritis, run by Indiana Hand to Shoulder Center at 1 site 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 5 inclusion and 10 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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: Physician decision). 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?
Visual Analogue Scale (VAS) (time frame: 2 weeks). The study lists 2 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 8 Oct 2024.