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NOT YET RECRUITING
NCT07755514

Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain

Sponsor: Giresun University

View on ClinicalTrials.gov

Summary

This prospective, controlled, observational cohort study will evaluate short-term changes in inflammatory biomarkers and subclinical cardiac function in adults with peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care. A total of 75 participants will be enrolled: 25 patients starting gabapentin, 25 patients starting pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain. Treatment selection and dose adjustments will be determined by the treating physician and will not be assigned by the study investigators. Participants will be assessed at baseline and again after 30 ± 7 days. Assessments will include clinical information, pain severity, routine laboratory results, inflammatory biomarkers, and standard transthoracic echocardiography. No additional blood will be collected solely for research; leftover serum from routine testing will be used. The primary aim is to compare changes over time between the gabapentin and pregabalin groups, while the healthy control group will provide a reference for interpretation.

Official title: Translational Analysis of Changes in Inflammatory Biomarkers and Subclinical Cardiac Function Associated With Gabapentin and Pregabalin Use in Patients With Peripheral Neuropathic Pain: A Prospective Controlled Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2026-08-15

Completion Date

2026-10-15

Last Updated

2026-08-10

Healthy Volunteers

Yes

Interventions

DRUG

Gabapentin

Gabapentin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.

DRUG

Pregabalin

Pregabalin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.