Evaluating nerve injections for treating pudendal neuralgia pain
EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM
This study is testing if injections of lidocaine into the pudendal nerve can help adults with pudendal neuralgia pain who haven't found relief from regular medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06872437 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed pudendal neuralgia who have not responded to standard drug treatments.
Not a fit: Patients with ongoing infections, certain neurological or psychiatric conditions, or those on anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from pudendal neuralgia.
How similar studies have performed: While there is limited consensus on the best treatment for pudendal neuralgia, previous studies have shown mixed results with similar infiltration approaches, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- Hôpital Croix Saint-Simon — Paris, France (Recruiting)
Study contacts
- Principal investigator: Axel EGAL, Doctor — Groupe Hospitalier Diaconesses Croix Saint-Simon
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.