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RECRUITING
NCT06872437
PHASE3

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.

Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-12-08

Completion Date

2029-03-08

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DRUG

Lidocaine Injectable Solution

Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx),

DRUG

Saline Solution for Block

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)

Hôpital Croix Saint-Simon

Paris, France