LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Inflammatory bowel disease | Crohn's disease | Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- The inclusion criteria for the WP1 are: patients suffering from abdominal pain (pain score >3 at least two days a week during the last month) in a context of IBD, both Crohn’s disease or UC, and recruited from the gastroenterology consultation of Prof. Edouard Louis, Prof. Catherine Reenaers and Dr Sophie Vieujean (CHU Liege), being 18 years old or more, women or men. The patient has to be under optimal treatment for the disease, which has to be controlled, with no IBD treatment modification in the past 3 months (left to the discretion of the gastroenterologist). All patients must be capable to speak, understand, read and write in French. For WP2, the inclusion criteria for the patients are the same as WP1. Recruited volunteers will not suffer from IBD nor chronic abdominal pain and will be matched to patients of the same WP according to the age, sex, weight, and height."}

Exclusion criteria

• {"criterion_text":"- The exclusion criteria for WP1 and WP2 will be the following: renal insufficiency (exclueded by a blood sample from maximum one year), hepatic insufficiency (exclueded by a blood sample from maximum one year), hypersensitivity to the active ingredient or to one of the excipients or to local anesthetics of the amide type, cardiac conduction disorders, cardiac insufficiency, ongoing anticoagulant therapy, history of convulsion, injection site infection, shock state, history of malignant hyperthermia, refusal of the patient, pregnancy, breast-feeding woman, ongoing treatment with analgesics specifically targeting neuropathic pain (pregabalin, gabapentin, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), serotonin and noradrenaline reuptake inhibitors (SNRI)), neurological or psychiatric disorders, seizures, history of alcohol or drug abuse. In addition, treatment of IBD cannot be modified during the trial. Patients are also excluded if they take medications that have interactions with lidocaine, including beta-blockers, digitalin derivatives, cimetidine, barbituric, rifampicin, isoprenaline, glucagon, phenytoin, tocainide, mexiletine, and amiodarone. An acute/sudden, severe, sharp and constant or worsening in intensity abdominal pain is also an exclusion criterion. For WP2, contraindications to MRI will be added as exclusion criteria, including metallic devices such as a pacemaker, vascular clips, some ocular implants, cochlear implants, stent for less than 6 months, …). A complete metal checklist will be verified with each participant before allowing them to enter the MRI suite."}

Primary endpoints

• {"endpoint_text":"- We hope to be able to reduce the background pain scores and decrease the frequency of hyperalgesia flare-ups, and thus reduce the psychosocial impacts associated in these patients.","definition_or_measurement_approach":"Primary objective (first phase): demonstrate a reduction in pain intensity of at least 50%, as assessed by a visual analog scale, after an intravenous lidocaine infusion. Second phase: study changes in brain connectivity after intravenous lidocaine infusion and compare with healthy volunteers."}

Methods

• Recruited from the gastroenterology consultation of Prof. Edouard Louis, Prof. Catherine Reenaers and Dr Sophie Vieujean (CHU Liege) for patients with IBD.
• Healthy volunteers recruited (matched to patients by age, sex, weight, and height); volunteers will not suffer from IBD nor chronic abdominal pain.

Belgium

Earliest CTIS Part Ii Submission Date

26-06-2024

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

618

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

CHU De Liege

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium