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

Early Phase 1WithdrawnNCT04613024

Stanford University

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Weight Loss Pain, Postoperative

Interventions

TopamaxDRUG

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

GabapentinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Palo Alto, United States Minor Outlying Islands

Outcomes

Primary Outcomes

Determine the reduction in Opioid Consumption

Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control.

Time frame: 3 months

Evaluate the Side Effect Profiles of Topiramate

Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs

Time frame: 3 months

Evaluate the Side Effect Profiles of gabapentin

Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs

Time frame: 3 months

Secondary Outcomes

Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin

Harris hip score will be calculated after randomization at the pre-operative visit. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

Time frame: 1 week

Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks

Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

Time frame: 2 week

Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks

Data from ClinicalTrials.gov

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