TerminatedPhase 4

Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

Stopped: Physician decision

United States23 participantsStarted 2022-09-13

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * \<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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale (VAS)

Timeframe: 2 weeks

Number of Narcotic Pills Used

Timeframe: 2 weeks

Trial details

NCT IDNCT05556356

SponsorIndiana Hand to Shoulder Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-06

View on ClinicalTrials.gov More Carpometacarpal Osteoarthritis trials