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.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lidocaine Injectable Solution

    Drug

    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

    Drug

    Infiltration 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

60 Participants
are divided into 2 treatment groups
Group A: LidocaineActive comparator 1 intervention
Group B: Saline solutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
between inclusion and 1 month after the first injection.

Secondary outcomes

Other outcomes

Sponsors and contacts

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