Actively Recruiting
EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION
Led by Groupe Hospitalier Diaconesses Croix Saint-Simon · Updated on 2024-10-01
60
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, France, 75020
Actively Recruiting
Research Team
V
Valérie Millul, RC manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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