In short
There is currently 1 ongoing clinical trial investigating treatment options for chronic idiopathic pain syndrome. This trial is focused on managing persistent pain in the ano-perineal region using a local anesthetic approach. The study is being conducted in France and aims to evaluate whether lidocaine injections can provide effective pain relief for patients who have not responded to standard treatments.
Clinical trial locations
Study on the Effectiveness of Lidocaine and Sodium Chloride for Treating Chronic Ano-Perineal Pain in Adults
This clinical trial is investigating a treatment approach for chronic idiopathic ano-perineal pain, which is persistent pain in the anal and perineal areas without a known cause. The condition can significantly affect daily activities and quality of life, especially when sitting, having bowel movements, or standing for long periods.
Main inclusion criteria: To participate in this study, patients must be 18 years of age or older and have chronic idiopathic ano-perineal pain. They must have undergone an MRI scan that shows no medical condition explaining the pain. Importantly, participants must have already tried standard first-line treatments such as one or two painkillers, anti-inflammatory drugs, or local treatments without success. Patients must also be affiliated with a social security plan and provide informed consent to participate.
Main exclusion criteria: Patients cannot participate if they have other medical conditions that could interfere with the study, are currently in another clinical trial, or have had recent surgery in the ano-perineal area. Those with allergies to local anesthetics, pregnant or breastfeeding women, and individuals with a history of drug or alcohol abuse are also excluded. Additionally, patients who cannot provide informed consent or have mental health conditions that could affect participation are not eligible.
Trial focus and goal: The study aims to evaluate the effectiveness of a procedure called a posterior perineal block, which involves injecting medication into the perineal area to manage pain. The trial is designed as a double-blind study, meaning neither the participants nor the researchers know which solution is being administered. This approach ensures unbiased results. The primary goal is to measure pain reduction one month after the injection using a visual analog pain scale, where a reduction of at least 3 points is considered significant. The study will also monitor pain relief maintenance over three months and assess factors such as anxiety, depression, and the impact of pain on daily life using standardized questionnaires.
Investigational treatment: Participants will receive either lidocaine hydrochloride monohydrate or sodium chloride (saline) through an injection. Lidocaine is a local anesthetic that works by blocking nerve signals in the body, which numbs the treated area and reduces pain sensation. The injection is performed under neurostimulation to ensure accuracy and effectiveness. The study will compare the results between those receiving the active anesthetic and those receiving the saline solution to determine if the lidocaine provides meaningful pain relief for this challenging condition.
Summary
Currently, only one clinical trial is actively recruiting patients with chronic idiopathic pain syndrome, specifically targeting ano-perineal pain. The trial is being conducted in France and represents an important effort to find effective treatments for patients who have not responded to conventional pain management approaches. The focus on lidocaine injections reflects an interest in localized treatment strategies that may offer relief without systemic side effects. This trial highlights the need for more research into chronic pain conditions that lack identifiable causes and remain difficult to treat with standard medications.
