Study on Pain Relief Using Lidocaine and Sodium Chloride in Patients with Chronic Inflammatory Bowel Disease and Abdominal Pain

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What is this study about?

This clinical trial is focused on patients with chronic inflammatory bowel disease (IBD), which includes conditions like Crohn’s disease and ulcerative colitis. These conditions often cause abdominal pain, which can significantly affect daily life. The study is investigating the effects of a treatment using lidocaine hydrochloride monohydrate, a medication commonly used for its pain-relieving properties. The treatment will be administered as an infusion, which means it will be given directly into the bloodstream through a vein.

The purpose of the study is to see if this treatment can reduce pain intensity by at least 50% in patients with IBD. The study will also explore how the treatment affects brain connectivity, which refers to how different parts of the brain communicate with each other. This will be compared between patients with IBD and healthy volunteers who do not have the disease. The study will involve two phases: the first phase will focus on pain reduction, and the second phase will examine changes in brain connectivity.

Participants will receive either the lidocaine infusion or a placebo and will be monitored to assess changes in their pain levels and brain activity. The goal is to reduce the background pain scores and decrease the frequency of hyperalgesia flare-ups, which are episodes of increased sensitivity to pain. By doing so, the study aims to lessen the psychosocial impacts associated with chronic pain in these patients. The trial is expected to provide valuable insights into the potential benefits of lidocaine for managing pain in IBD patients.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that the condition of chronic inflammatory bowel disease (IBD) is stable and that no changes in treatment have occurred in the past three months.

Participants must be experiencing abdominal pain with a pain score greater than 3 at least two days a week over the last month.

2 infusion preparation

Participants will be prepared for the administration of the medication. This involves setting up an intravenous (IV) line for the infusion of the study medication.

3 medication administration

The study involves the administration of two solutions: Linisol 1%, which contains lidocaine hydrochloride monohydrate, and NaCl 0.9% B. Braun, a sodium chloride solution.

These solutions will be administered through an infusion, which is a method of delivering medication directly into the bloodstream over a set period.

4 monitoring and assessment

After the infusion, participants will be monitored to assess the reduction in pain intensity. This will be measured using a visual analog scale, which is a tool to help quantify pain levels.

The primary goal is to achieve a reduction in pain intensity of at least 50%.

5 follow-up and evaluation

Participants will undergo follow-up evaluations to study changes in brain connectivity after the infusion. This involves comparing these changes with those observed in a group of healthy volunteers.

The study aims to understand the mechanisms behind the analgesic effect of lidocaine in patients with IBD.

Who Can Join the Study?

Patients must have abdominal pain with a pain score greater than 3, at least two days a week during the last month, in the context of Inflammatory Bowel Disease (IBD), which includes Crohn’s disease or Ulcerative Colitis (UC).
Patients must be 18 years old or older.
Both women and men can participate.
Patients must be under optimal treatment for their disease, which means their condition is controlled, and there should be no changes in their IBD treatment in the past 3 months, as decided by their gastroenterologist.
Patients must be able to speak, understand, read, and write in French.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Inflammatory Bowel Disease (IBD) cannot participate. IBD is a condition that causes inflammation in the digestive tract.
Patients who are not experiencing chronic abdominal pain related to IBD cannot participate. Chronic means the pain has been ongoing for a long time.
Patients who are under the age of 18 or over the age of 65 cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to lidocaine cannot participate. Lidocaine is a medication used to numb tissue in a specific area.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with significant medical conditions other than IBD that might interfere with the study cannot participate.
Patients who are unable to provide informed consent cannot participate. Informed consent means understanding the details of the study and agreeing to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre hospitalier universitaire de Liege	Liege	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.05.2024

Trial locations

Investigated drugs:

Lidocaine is a medication used in this clinical trial to help reduce pain. It is given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using lidocaine in this study is to see if it can lower the intensity of pain by at least 50% in patients who have chronic inflammatory bowel disease (IBD) and experience abdominal pain. Additionally, the study aims to explore how lidocaine affects brain connectivity in these patients and compare the results with those from healthy individuals. This could help researchers understand more about how lidocaine works in the body and its potential benefits for people with IBD-related pain.

Investigated diseases:

Inflammatory bowel disease

Inflammatory Bowel Disease – Inflammatory Bowel Disease (IBD) is a term primarily used to describe two conditions: Crohn’s disease and ulcerative colitis. These conditions involve chronic inflammation of the gastrointestinal tract. In Crohn’s disease, inflammation can occur anywhere along the digestive tract, often affecting the deeper layers of the bowel. Ulcerative colitis, on the other hand, is limited to the colon and rectum, primarily affecting the innermost lining. Symptoms of IBD can include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. The progression of IBD can vary, with periods of active symptoms followed by times of remission.

Trial ID:

2023-508224-35-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pain Relief Using Lidocaine and Sodium Chloride in Patients with Chronic Inflammatory Bowel Disease and Abdominal Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?