About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Lidocaine Injectable Solution
DrugInfiltration 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
DrugInfiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.