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Study on the Effectiveness of Lidocaine and Sodium Chloride for Treating Chronic Ano-Perineal Pain in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of chronic idiopathic ano-perineal pain, a condition characterized by persistent pain in the anal and perineal regions without a known cause. The study will use a local anesthetic called lidocaine, which is commonly used to numb tissues in a specific area, and a solution of sodium chloride, often referred to as saline. The purpose of the study is to evaluate the effectiveness of a procedure called a posterior perineal block, which involves injecting the anesthetic into the perineal area to manage pain.

Participants in the study will receive either the lidocaine solution or the saline solution through an injection. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which solution is being administered to ensure unbiased results. The main goal is to assess the reduction in pain one month after the injection. The study will also look at the maintenance of pain relief over a period of three months and other factors such as anxiety and depression levels, using various questionnaires and scales.

The trial aims to provide insights into the management of chronic idiopathic ano-perineal pain and determine if the local anesthetic infiltration is an effective treatment option. Participants will be monitored for changes in their pain levels and overall well-being throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, consent, social security affiliation, and the presence of chronic idiopathic ano-perineal pain.

    A review of previous treatments will be performed to ensure resistance to standard first-line medical treatments.

  2. Step 2

    Randomization

    Participants will be randomly assigned to one of two groups. One group will receive lidocaine hydrochloride monohydrate, and the other will receive sodium chloride (saline).

    This process is double-blind, meaning neither the participant nor the medical staff will know which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves an injection of the assigned solution into the affected area. This is known as infiltration.

    The injection is performed under neurostimulation to ensure accuracy and effectiveness.

  4. Step 4

    Follow-up at 1 month

    One month after the first injection, a follow-up assessment will be conducted.

    The primary goal is to evaluate the reduction in pain using a visual analog pain scale (VAS). A reduction of at least 3 points is considered significant.

  5. Step 5

    Follow-up at 3 months

    A second follow-up will occur three months after the initial injection.

    The focus will be on maintaining the positive response, with a continued reduction in pain scores.

  6. Step 6

    Additional assessments

    Throughout the trial, additional assessments will be conducted to evaluate the impact of pain on daily life, anxiety, depression, and central sensitization.

    These assessments will use standardized questionnaires and scales to ensure comprehensive evaluation.

Who can join the trial?

6 criteria

  • Patient must be 18 years of age or older.
  • Patient must express consent to participate in the study, meaning they agree to join the study after understanding what it involves.
  • Patient must be affiliated with or a beneficiary of a social security plan, which means they should have some form of health insurance or social security coverage.
  • Patient must have chronic idiopathic ano-perineal pain, which is long-lasting pain in the area around the anus and perineum with no known cause.
  • Patient must have a normal MRI or no medical condition found that explains the pain. An MRI is a type of scan that creates detailed images of the inside of the body.
  • Patient must have shown resistance to "standard" 1st-line medical treatment, meaning the usual pain relief methods like one or two painkillers, anti-inflammatory drugs (NSAIDs), or local treatments have not worked.

Who cannot join the trial?

8 criteria

  • Patients who have any other medical condition that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery in the ano-perineal area.
  • Patients who are allergic to local anesthetics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to provide informed consent.
  • Patients who have a mental health condition that could affect their ability to participate in the study.
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Investigated drugs

Local Anesthetic is a type of medication used to numb a specific area of the body to prevent pain during procedures. In this clinical trial, the local anesthetic is used to manage chronic idiopathic ano-perineal pain. The medication works by blocking the nerves in the affected area, which helps to reduce or eliminate the sensation of pain. This trial aims to evaluate how effective this approach is in relieving pain one month after the treatment.

What is already known about the treatment

Local Anesthetic – This medication is administered through an injection directly into the affected area, specifically targeting the posterior perineal region. It is currently being studied in clinical trials to assess its effectiveness in managing chronic idiopathic ano-perineal pain, a condition characterized by persistent pain in the anal and perineal areas without a known cause. The main therapeutic indication for this local anesthetic is pain relief in the specified region. At the molecular level, it works by blocking nerve signals in the body, which helps to numb the area and reduce pain sensation. It is classified pharmacologically as a local anesthetic, which is a type of medication used to cause temporary loss of sensation in a specific area.

Investigated diseases

Chronic Idiopathic Ano-Perineal Pain – This condition is characterized by persistent pain in the anal and perineal regions without an identifiable cause. The pain is often described as a constant or intermittent ache, which can vary in intensity. It may be exacerbated by sitting, bowel movements, or prolonged standing. The progression of the pain can lead to significant discomfort and may affect daily activities and quality of life. Over time, individuals may experience increased sensitivity in the affected area. The condition is considered idiopathic, meaning the exact cause of the pain remains unknown.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518148-19-00Protocol codeRI-B-2021-7300-07Estimated enrolment60 patientsSponsorGroupe Hospitalier Diaconesses Croix Saint Simon

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