drugset / Trial / NCT06872437

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.

NCT06872437 ↗

Phase 3 Recruiting 60 enrolled Groupe Hospitalier Diaconesses Croix Saint-Simon
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-12-08
Primary completion
2029-03-08
Completion
2029-03-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 6 ml Other
Comparator Lidocaine Other / unclassified 10 mg/ml Other

Indications