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

Pain, Postoperative Clinical Trial

Official title:

Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04613024
• Other study ID #: 56915
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2023
• Source: Stanford University
• Contact: Derek Amanatullah, Md PhD
• Phone: 6507232257
• Email: arprerna[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Weight Loss

Intervention

Drug:
• Topamax
Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval
• Gabapentin
Control group will be prescribed gabapentin after surgery with follow up at regular interval

Locations

Country	Name	City	State
United States Minor Outlying Islands	Stanford University	Palo Alto

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States Minor Outlying Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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	3 months
Primary	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	3 months
Secondary	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.	1 week
Secondary	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.	2 week
Secondary	Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 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.	6week
Secondary	Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months	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.	3 months
Secondary	SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months	SF12 will be calculated after surgery	3 months
Secondary	SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks	SF12 will be calculated after surgery	2 week
Secondary	SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks	SF12 will be calculated after surgery	6 week
Secondary	SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week	SF12 will be calculated after surgery	1 week
Secondary	WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks	WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores	6 week
Secondary	WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks	WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores	2 week
Secondary	WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months	WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores	3 months
Secondary	WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months	WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores	1 week