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

NCT ID: NCT05556356

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2024-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Preoperative multivitamin and postoperative standardized pain management regimen

Group Type: PLACEBO_COMPARATOR

Placebo: Multivitamin

Intervention Type: OTHER

pre-operative Multivitamin

Test Group

: Preoperative acetaminophen and postoperative standardized pain management regimen

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

pre-operative acetaminophen (1000mg)

Interventions

Acetaminophen

pre-operative acetaminophen (1000mg)

Intervention Type: DRUG

Placebo: Multivitamin

pre-operative Multivitamin

Intervention Type: OTHER

Other Intervention Names

Tylenol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Hand to Shoulder Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IU15386

Identifier Type: -

Identifier Source: org_study_id