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

Carpometacarpal Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556356
• Other study ID #: IU15386
• Status: Recruiting
• Phase: Phase 4
• Start date: September 13, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Indiana Hand to Shoulder Center
• Contact: Lexie Reissaus, CCRP
• Phone: 317-471-4312
• Email: lreissaus[@]ihtsc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Carpometacarpal Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• Acetaminophen
pre-operative acetaminophen (1000mg)

Other:
• Placebo: Multivitamin
pre-operative Multivitamin

Locations

Country	Name	City	State
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Hand to Shoulder Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)	2 weeks
Primary	Number of Narcotic Pills Used	Number of Narcotic Pills Used	2 weeks