EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Croix Saint-Simon
RECRUITING
Paris
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2029-03-08
Participants
Target number of participants: 60
Treatments
Active_comparator: Lidocaine
Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx)
Placebo_comparator: Saline solution
Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)
Related Therapeutic Areas
Sponsors
Leads: Groupe Hospitalier Diaconesses Croix Saint-Simon

This content was sourced from clinicaltrials.gov