Efficacy of Lidocaine Local Anaesthetic Infiltration Compared With Placebo for Pudendal Neuralgia Treatment in a Randomized Trial

What this Trial Is About

Pudendal neuralgia (PN) is a chronic nerve compression syndrome that causes neuropathic pain similar to carpal tunnel syndrome. Treatments currently include medication, nerve infiltrations, and decompressive surgery. This research aims to compare the usual local anesthetic infiltration treatment under neurostimulation with a placebo, as no type of infiltration has been previously tested against placebo, despite the likelihood of a large placebo effect in this condition. The study focuses on patients who have not responded to standard drug treatments for neuropathic pain. Participants will receive either injections of lidocaine (6mL of 10 mg/mL) or saline solution at specific sites around the pudendal nerve (left and right ischioanal fossae and coccyx). The treatments are given under neurostimulation guidance. The study is randomized and single-blinded, comparing the effectiveness of lidocaine infiltration against placebo saline infiltration. During the study, participants will be monitored for pain relief using a visual analogue scale (VAS) at inclusion and one month after the first injection. The main outcome is the proportion of patients experiencing a pain reduction of at least 3 points on the VAS. The study involves regular assessments to evaluate treatment response and safety. Participation includes consent and ongoing evaluation for one month following treatment, with further follow-up as needed.

Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Neurostimulation on Pain, 1 Month After an Infiltration of Local Anaesthetic, in the Treatment of Pudendal Neuralgia.