Evaluating local anesthetic infiltration for chronic ano-perineal pain relief
EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION : a RANDOMIZED DOUBLE-BLIND SALINE-CONTROLLED TRIAL
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06602349 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown some success with similar local anesthetic infiltration techniques, but this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Paris, Île-de-France Region
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.