Evaluating nerve injections for treating pudendal neuralgia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of therapeutic infiltrations of the pudendal nerve using lidocaine, compared to a saline placebo, in alleviating pain associated with pudendal neuralgia. Participants will be adults who have experienced treatment failure with standard medications for neuropathic pain. The study will measure pain relief one month after the infiltration, focusing on the potential benefits of this intervention in a population that has limited options for effective pain management. The research seeks to establish a clearer understanding of the efficacy of nerve infiltration treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient 18 years of age or older,
* Expressed consent to participate in the study
* Affiliated or beneficiary of a social security plan
* With pudendal neuralgia (Nantes criteria "modified" Nantes criteria).
* MRI normal or without pathology explaining the pain
* Drug treatment failure as defined in the LOS, i.e., failure (VAS decrease \< 3) of at least one antiepileptic drug and an antidepressant whose dosages have been to the maximum possible dosage, or in whom a side effect for whom a side effect could not allow the dose to be increased to its to its maximum allowed dose.

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress
* Known neurological pathology that may explain the pain
* Psychiatric pathology requiring a drug treatment treatment
* Anticoagulants or haemostasis disorders
* Hypersensitivity to lidocaine hydrochloride, to local anesthetics
* Recurrent porphyrias

Where it's running

• Hôpital Croix Saint-Simon
  Paris, France Recruiting

Study contacts

• Principal investigator: Axel EGAL, Doctor — Groupe Hospitalier Diaconesses Croix Saint-Simon

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.