CClinicalTrials.gg
TerminatedNCT05556356Updated Oct 8, 2024

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

A Phase 4 interventional study of Acetaminophen and Placebo: Multivitamin in Carpometacarpal Osteoarthritis, sponsored by Indiana Hand to Shoulder Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Indiana Hand to Shoulder Center · Phase 4, Interventional, and Other

Why this study was terminated
Physician decision

From the registry’s dates

  • Primary completion was May 2024, 2 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carpometacarpal Osteoarthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 23 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Indiana Hand to Shoulder Center is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
23 participants (actual)

Study arms

  • Placebo comparator
    Control Group

    Preoperative multivitamin and postoperative standardized pain management regimen

    Other: Placebo: Multivitamin

  • Experimental
    Test Group

    : Preoperative acetaminophen and postoperative standardized pain management regimen

    Drug: Acetaminophen

Interventions

  • DrugAcetaminophen

    pre-operative acetaminophen (1000mg)

    Also known as: Tylenol

  • OtherPlacebo: Multivitamin

    pre-operative Multivitamin

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)

    Time frame: 2 weeks

  2. Number of Narcotic Pills Used

    Number of Narcotic Pills Used

    Time frame: 2 weeks

07

Study locations

1 site
  • Indiana Hand to Shoulder Center
    Indianapolis, Indiana 46260, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05556356
Lead sponsor
Indiana Hand to Shoulder Center
Responsible party
Sponsor
First posted
Sep 27, 2022
Start date
Sep 13, 2022
Primary completion
May 6, 2024
Completion
May 6, 2024
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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