Steroid shots vs. numbing shots: which calms trapped pelvic nerves?
NCT ID NCT00851513
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Pudendal neuralgia is a painful condition caused by a trapped nerve in the pelvis. Researchers at Nantes University Hospital are comparing three injection mixtures placed near the pudendal nerve: lidocaine alone, lidocaine plus a steroid, and lidocaine plus steroid plus a large volume of saline. They will measure pain relief after three months in adults who have had the condition for more than six months. The goal is to see whether adding steroids or extra fluid improves results over numbing medicine alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pudendal nerve injections combining lidocaine, a local steroid, and saline
- What this could lead to
- If one injection mix works better, doctors could have a clearer, evidence-based way to ease the severe pelvic pain of pudendal neuralgia without surgery.
- What could go wrong
- Injections near the pudendal nerve can cause bleeding, infection, or temporary numbness, and the trial may show that adding steroids or extra fluid makes little difference to pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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202 people
The number who actually took part.
- Start date
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Nov 2008
- Finished
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Feb 2011
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH de la Côte Basque
Bayonne, 64100, France
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CHU Clermont-Ferrand
Clermont-Ferrand, 63058, France
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CHU de Nantes
Nantes, 44093, France
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Catherine de Sienne
Nantes, 44200, France
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Centre MARIENIA
Cambo-les-Bains, 64250, France
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Hospices Civils de Lyon
Lyon, 69495, France
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Hôpital Charles Nicolle
Rouen, 76031, France
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Hôpital Rothschild
Paris, 75571, France
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Scanner Saint Hilaire
Rouen, 76000, France
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