Clincosm LogoSign in Get a demo

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

Sponsor
Indiana Hand to Shoulder Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05556356
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
11.6
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Actual Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Scale (VAS) [2 weeks]

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

    2. Number of Narcotic Pills Used [2 weeks]

      Number of Narcotic Pills Used

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • <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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana Hand to Shoulder Center Indianapolis Indiana United States 46260

    Sponsors and Collaborators

    • Indiana Hand to Shoulder Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Indiana Hand to Shoulder Center
    ClinicalTrials.gov Identifier:
    NCT05556356
    Other Study ID Numbers:
    • IU15386
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Sep 30, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis
    Acetaminophen

    Study Results

    No Results Posted as of Sep 30, 2022