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

October 1, 2024 updated by: Indiana Hand to Shoulder Center
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Indiana Hand to Shoulder Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Preoperative multivitamin and postoperative standardized pain management regimen
Other: Placebo: Multivitamin
pre-operative Multivitamin
Experimental: Test Group
: Preoperative acetaminophen and postoperative standardized pain management regimen
Drug: Acetaminophen
pre-operative acetaminophen (1000mg)
Other Names:
  • Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 2 weeks
Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
2 weeks
Number of Narcotic Pills Used
Time Frame: 2 weeks
Number of Narcotic Pills Used
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana Hand to Shoulder Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

May 6, 2024

Study Completion (Actual)

May 6, 2024

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU15386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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