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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05556356
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Indiana Hand to Shoulder Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Carpometacarpal Osteoarthritis
Arms & Interventions

Arms

Placebo Comparator: Control Group

Preoperative multivitamin and postoperative standardized pain management regimen

Experimental: Test Group

: Preoperative acetaminophen and postoperative standardized pain management regimen

Interventions

Drug: - Acetaminophen

pre-operative acetaminophen (1000mg)

Other: - Placebo: Multivitamin

pre-operative Multivitamin

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Indiana Hand to Shoulder Center, Indianapolis, Indiana

Status

Recruiting

Address

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260

Site Contact

Lexie Reissaus, CCRP

[email protected]

317-471-4312

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