Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia

Study Overview
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Brief Summary
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Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with: neuropathic pains treatment specific kinesitherapy Alcock's canal and sacrospinal ligament infiltrations under scan with diagnostic block local steroids injections and surgical decompression of pudendal nerve with transrectal approach. Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies. The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament: group A: only local anesthetic (control arm) group B: local anesthetics associated with local steroids group C: local anesthetics associated with local steroids and important volumes of physiological serum

Conditions
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Pudendal Neuralgia, Canal Syndrome

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Depmedrol
* Other: physiological serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting the four indispensable clinical criteria for pudendal neuralgia (Nantes' criteria) Man or woman aged more than 18 years old Suffering from pudendal neuralgia since more than six months Without previous infiltration identical to the one proposed by the protocol Without previous surgery of pudendal nerve Without any hemorrhagic risk factor No contra-indication to Lidocaïne, Depo-medrol or contrast-product injections Pain intensity with an average > or = 40/100 (measured by scales during the fifteen days before infiltration) Exclusion Criteria: Patient presenting one of the four exclusion clinical criterium for pudendal neuralgia (Nantes' criteria) Patient who has filled his pain note book during less than 5 days over the 15 days before the infiltration Pregnancy Depression (Beck scale > 16/39)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>local anesthetics (lidocaine) associated with local steroids (depo-medrol) | Drug: Lidocaine<br>* local anesthetics<br>Drug: Depmedrol<br>* local steroids<br>|
| Experimental: Group C<br>local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum | Drug: Lidocaine<br>* local anesthetics<br>Drug: Depmedrol<br>* local steroids<br>Other: physiological serum<br>* important volumes of physiological serum<br>|
| Active Comparator: Group A<br>only local anesthetic (lidocaine) | Drug: Lidocaine<br>* local anesthetics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective is to evaluate, after 3 months, the therapeutical efficacy on pain of steroids pudendal nerve infiltration, in patients suffering from pudendal neuralgia with canal syndrome |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pudendal neuralgia, pudendal nerve, Alcock's canal syndrome, Canal syndrome, neuropathic pain, infiltration, randomized protocol, pain scales