A phase 1 study of an injectable lidocaine paste for spermatic cord block in men with chronic scrotal content pain.

ABSTRACT:

Introduction

Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.

Methods

This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine poly

SUBMITTER: Witherspoon LDE 

PROVIDER: S-EPMC10382213 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature