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EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION

Study acronym: EPHI-DACI
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Study title shortened, about 7 wordsv3
  3. Study description revised
    • Study title expanded, about 5 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06602349
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions
(from sponsor)		 Chronic Idiopathic Anopérineal Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov