Evaluating local anesthetic infiltration for chronic ano-perineal pain relief
Official title: EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION : a RANDOMIZED DOUBLE-BLIND SALINE-CONTROLLED TRIAL
Run by Groupe Hospitalier Diaconesses Croix Saint-Simon · NCT06602349 · Data updated 2026-11-12
This study is testing if a local anesthetic injection can help people with chronic ano-perineal pain feel better and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | December 8, 2023 |
| Main results expected | December 8, 2028 |
| Study ends | March 8, 2029 |
| Registry record updated | October 1, 2024 |
| Trial ID | NCT06602349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with chronic idiopathic ano-perineal pain who have not responded to standard first-line medical treatments.
✕Probably not a fit
Patients with known neurological or psychiatric conditions that could explain their pain, or those currently on anticoagulants, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of a posterior perineal block using local anesthetic infiltration in patients suffering from chronic idiopathic ano-perineal pain. Participants will receive either lidocaine or saline, and their pain levels will be evaluated one month after the procedure. The study will also monitor the maintenance of pain relief at three months, changes in quality of life, and the psychological impact of pain. The trial seeks to provide insights into the management of this challenging condition.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with chronic idiopathic ano-perineal pain.
How similar studies have gone: Previous studies have shown some success with similar local anesthetic infiltration techniques, but this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Valérie Millul, RC manager
- Email: vmillul@hopital-DCSS.org
- Phone: +33 1 44 64 16 29
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.