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.
EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM
Groupe Hospitalier Diaconesses Croix Saint-Simon
60 participants
Dec 8, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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
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Interventions
Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx),
Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)
Locations(1)
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NCT06872437