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

Study Overview
=================
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.

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

Conditions
-----------------
Carpometacarpal Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Other: Placebo: Multivitamin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Preoperative multivitamin and postoperative standardized pain management regimen | Other: Placebo: Multivitamin<br>* pre-operative Multivitamin<br>|
| Experimental: Test Group<br>: Preoperative acetaminophen and postoperative standardized pain management regimen | Drug: Acetaminophen<br>* pre-operative acetaminophen (1000mg)<br>* Other names: Tylenol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |