NCT06602349 EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION
| NCT ID | NCT06602349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon |
| Condition | Chronic Idiopathic Anopérineal Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-08 |
| Primary Completion | 2028-12-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-12-08 with a primary completion date of 2028-12-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of a posterior perineal block performed under neurostimulation at 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain. The main questions aims to answer are : 1. The efficacy of a posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain. 2. The rate of maintenance at 3 months of a positive response to the first infiltration. 3. The pain-free rate at 1 month after the first infiltration. 4. Evolution of quality of life and pain impact between inclusion and one month after the first infiltration. 5. Changes in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration. 6. The evolution of symptoms related to central sensitization (both somatic and emotional) between inclusion and one month after the first infiltration. Participants will : * be managed with a posterior perineal block of lidocaine or saline solution under neurostimulation. * complete a questionnaire on pain, anxiety and depression at inclusion and one month after injection of the research product (lidocaine or saline solution). Researchers will compare between the two treatment arms (lidocaine versus saline solution) to see the rate of patients with a reduction of at least 3 points on a visual analog pain scale between inclusion and 1 month after the first injection.
Eligibility Criteria
Inclusion Criteria: * Patient 18 years of age or older, * Express consent to participate in the study * Affiliated or beneficiary of a social security plan * Presenting chronic idiopathic ano-perineal pain * MRI normal or without pathology explaining pain (Multidisciplinary consultation meeting reread if in doubt) * Resistance to \"standard\" 1st-line medical treatment (level 1 or 2 analgesics and/or non-steroidal anti-inflammatory and/or local topicals) Exclusion Criteria: * Patient benefiting from a legal protection measure * Pregnant or breast-feeding woman * General and/or local infection (fistulous or cutaneous suppuration of anal margin) in progress * Known neurological pathology that may explain pain * Psychiatric pathology requiring medication * Anticoagulants or haemostasis disorders * Hypersensitivity to lidocaine hydrochloride or local anesthetics * Recurrent porphyrias
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06602349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Idiopathic Anopérineal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06602349 currently recruiting?
Yes, NCT06602349 is actively recruiting participants. Contact the research team at vmillul@hopital-DCSS.org for enrollment information.
Where is the NCT06602349 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06602349 clinical trial?
NCT06602349 is sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. The trial plans to enroll 60 participants.