EFFICACY OF ROUTINE MANAGEMENT BY LOCAL ANAESTHETIC INFILTRATION IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL AGAINST SALINE
- Conditions
- Patients with pudendal neuralgia who have failed drug treatmentTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2021-001494-23-FR
- Lead Sponsor
- Groupe Hospitalier Diaconesses-Croix-Saint-Simon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Patient 18 years of age or older,
- Express consent to participate in the study
- Affiliated or beneficiary of a social security plan
- With pudendal neuralgia (modified Nantes criteria).
- MRI normal or without pathology explaining the pain
- Failure of drug treatment as defined in the NPs, i.e. failure (VAS decrease < 3) of at least one antiepileptic and one antidepressant whose dosages were brought to the maximum possible or in whom a side effect did not allow the dose to be increased to its maximum allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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 medical treatment
- Anticoagulants or haemostasis disorders
- Hypersensitivity to lidocaine hydrochloride, local anaesthetics
- Recurrent porphyrias
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method