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

NCT06602349 | Recruiting DMC

• 1 other identifier: 2021-001494-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 :

• 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

Chronic Idiopathic Anopérineal Pain

Keywords

LIDOCAINE; posterior perineal block; randomized, double-blind; Salin solution; chronic idiopathic ano-perineal pain

Outcome Measures

Primary Outcomes (1)

• Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection.

  Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS)(lower value is 0 and means no pain, higher is 10 means the maximum of pain) between inclusion and 1 month after the first injection. The rate of successful patients at M1 between the two randomization arms will be analyzed using logistic regression, with treatment success or failure as the explanatory variable and randomization arm and duration of pain (stratification factor) as the explanatory variables.

  3 month

Study Arms (2)

experimental ARMS

EXPERIMENTAL

treated with lidocaine 10 mg/ml

Drug: Lidocaine 10 MG/ML

placebo arm

PLACEBO COMPARATOR

treated with placebo;salin solution

Drug: Saline

Interventions

Lidocaine 10 MG/ML DRUG

administration of lidocaine in posterior perineal block infiltration

experimental ARMS

Saline DRUG

administration of salin solution in posterior perineal block infiltration

placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

RECRUITING

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Valérie Millul, RC manager

CONTACT

+33 1 44 64 16 29; vmillul@hopital-DCSS.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 8, 2028
• Study Completion (Estimated): March 8, 2029
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

FR (1)