Clinical trial NCT04613024: Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty
Official title: Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Weight Loss
Pain, Postoperative
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Determine the reduction in Opioid Consumption
timeFrame: 3 months
measure: Evaluate the Side Effect Profiles of Topiramate
timeFrame: 3 months
measure: Evaluate the Side Effect Profiles of gabapentin
timeFrame: 3 months
Secondary outcomes:
measure: Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin
timeFrame: 1 week
measure: Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
timeFrame: 2 week
measure: Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
timeFrame: 6week
measure: Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
timeFrame: 3 months
measure: SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
timeFrame: 3 months
measure: SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks
timeFrame: 2 week
measure: SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
timeFrame: 6 week
measure: SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week
timeFrame: 1 week
measure: WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
timeFrame: 6 week
measure: WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
timeFrame: 2 week
measure: WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
timeFrame: 3 months
measure: WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
timeFrame: 1 week
Other outcomes:
Locations:
city: Palo Alto
country: United States Minor Outlying Islands
facility: Stanford University
Study officials:
References: