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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05556356
Enrollment
23
Registered
2022-09-27
Start date
2022-09-13
Completion date
2024-05-06
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpometacarpal Osteoarthritis

Brief 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.

Interventions

DRUGAcetaminophen

pre-operative acetaminophen (1000mg)

OTHERPlacebo: Multivitamin

pre-operative Multivitamin

Sponsors

Indiana Hand to Shoulder Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants unblinded following final data collection.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)2 weeksPatients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Number of Narcotic Pills Used2 weeksNumber of Narcotic Pills Used

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026