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

NCT ID: NCT04613024

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Weight Loss Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experiment

Topamax randomized group

Group Type EXPERIMENTAL

Topamax

Intervention Type DRUG

Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval

Control

Gabapentin randomized group

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Control group will be prescribed gabapentin after surgery with follow up at regular interval

Interventions

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Topamax

Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval

Intervention Type DRUG

Gabapentin

Control group will be prescribed gabapentin after surgery with follow up at regular interval

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Derek Amanatullah

Assistnat professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Palo Alto, , United States Minor Outlying Islands

Site Status

Countries

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United States Minor Outlying Islands

Other Identifiers

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56915

Identifier Type: -

Identifier Source: org_study_id

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