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

Indiana Hand to Shoulder Center

Status and phase: Terminated; Phase 4

Conditions: Carpometacarpal Osteoarthritis

Treatments: Drug: Acetaminophen; Other: Placebo: Multivitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT05556356

IU15386

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Preoperative multivitamin and postoperative standardized pain management regimen

Treatment:

Other: Placebo: Multivitamin

Test Group

Experimental group

Description:

: Preoperative acetaminophen and postoperative standardized pain management regimen

Treatment:

Drug: Acetaminophen