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

NCT05556356 | Terminated Phase 4 FDA Drug

• 1 other identifier: IU15386
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpometacarpal Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

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

  2 weeks

• Number of Narcotic Pills Used

  Number of Narcotic Pills Used

  2 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Preoperative multivitamin and postoperative standardized pain management regimen

Other: Placebo: Multivitamin

Test Group

EXPERIMENTAL

: Preoperative acetaminophen and postoperative standardized pain management regimen

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

pre-operative acetaminophen (1000mg)

Also known as: Tylenol

Test Group

Placebo: Multivitamin OTHER

pre-operative Multivitamin

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants unblinded following final data collection.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: September 13, 2022
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)