RecruitingPhase 3NCT06872437

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


Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Enrollment

60 participants

Start Date

Dec 8, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lidocaine Injectable Solution and a drug called Saline Solution for Block for people with pudendal neuralgia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine 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),

DRUGSaline 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

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NCT06872437


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