Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Neurostimulation on Pain, 1 Month After an Infiltration of Local Anaesthetic, in the Treatment of Pudendal Neuralgia.
Lidocaine Injectable Solution: Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx),
Saline Solution for Block: Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)
Study summary
Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery. Medicinal treatment involves the use of drugs that have proved effective in other areas, such as shingles or diabetes. There is no consensus on the molecules to be used for pudendal nerve infiltration (PNTI), and less than half of patients experience short-term relief. The only risk factor for failure is the duration of pain. Our study proposes to compare the usual treatment with a placebo, as no type of infiltration has been compared with a placebo.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Comparison between the two treatment arms (lidocaine vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and — between inclusion and 1 month after the first injection.
Trial sites (1)
Facility
City
Region
Status
Hôpital Croix Saint-Simon
Paris
France
Recruiting
More Groupe Hospitalier Diaconesses Croix Saint-Simon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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