Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty

Stanford University

Status and phase: Withdrawn; Early Phase 1

Conditions: Weight Loss; Pain, Postoperative

Treatments: Drug: Gabapentin; Drug: Topamax

Study type: Interventional

Funder types: Other

Identifiers

NCT04613024

56915

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery

Full description

Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI >30 and <40 kg/m2, or >40 kg/m2
• Patients refusing bariatric surgery or having had prior bariatric surgery

Exclusion Criteria

• Patients will be ineligible to participate if they have any of the following:
• known topiramate or gabapentin allergy
• history of seizure disorder
• chronic opiate use pre-operatively
• history of nephrolithiasis
• history of acute angle closure glaucoma
• recurrent major depression
• presence or history of suicidal behavior or ideation with intent to act
• current substantial depressive symptoms (Patient Health Questionnaire total score >10), pregnancy
• child-bearing potential and not on contraception
• age <18 years
• major neurocognitive disorder
• metabolic acidosis
• incarcerated status
• bilateral surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Experiment

Experimental group

Description:

Topamax randomized group

Treatment:

Drug: Topamax

Control

Active Comparator group

Description:

Gabapentin randomized group

Treatment:

Drug: Gabapentin