EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION
RecruitingNot applicableNCT06602349
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION : a RANDOMIZED DOUBLE-BLIND SALINE-CONTROLLED TRIAL
- Conditions
- Chronic Idiopathic Anopérineal Pain
- Interventions
- Drug: Lidocaine 10 MG/ML
- Drug: Saline
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Start date
- 2023-12-08
- Primary completion
- 2028-12-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06602349