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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Experimental | local anesthetics (lidocaine) associated with local steroids (depo-medrol) |
|
| Group C | Experimental | local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum |
|
| Group A | Active Comparator | only local anesthetic (lidocaine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | local anesthetics |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jacques LABAT | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de la Côte Basque | Bayonne | 64100 | France | |||
| Centre MARIENIA |
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| Depmedrol |
| Drug |
local steroids |
|
| physiological serum | Other | important volumes of physiological serum |
|
| Cambo-les-Bains |
| 64250 |
| France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63058 | France |
| Hospices Civils de Lyon | Lyon | 69495 | France |
| CHU de Nantes | Nantes | 44093 | France |
| Catherine de Sienne | Nantes | 44200 | France |
| Hôpital Rothschild | Paris | 75571 | France |
| Scanner Saint Hilaire | Rouen | 76000 | France |
| Hôpital Charles Nicolle | Rouen | 76031 | France |
| ID | Term |
|---|---|
| D060545 | Pudendal Neuralgia |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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