Abdominal pain – Trials in Disease

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Ongoing Clinical Trials for Abdominal Pain

There are currently 3 clinical trials investigating different approaches to managing abdominal pain. These studies are exploring pain relief treatments for chronic inflammatory bowel disease, prevention of chronic pain after hernia surgery, and improved diagnostic imaging for acute abdominal pain in patients with reduced kidney function. Trials are being conducted in Belgium, Spain, Finland, and Norway.

Clinical trial locations

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

This trial is focused on people living with chronic inflammatory bowel disease, which includes Crohn’s disease and ulcerative colitis. These conditions often cause ongoing pain that can make daily life difficult. The study is testing whether lidocaine hydrochloride monohydrate, a medication known for its pain-relieving properties, can help reduce this type of pain when given directly into the bloodstream through an infusion.

Who can participate: Adults aged 18 or older with inflammatory bowel disease who experience pain scores greater than 3 at least two days per week during the past month. Participants must be on stable treatment with no changes in the past three months as determined by their gastroenterologist. Both men and women can join, but they must be able to speak, understand, read, and write in French.

Who cannot participate: People without inflammatory bowel disease, those under 18 or over 65 years old, pregnant or breastfeeding women, anyone with a history of allergic reactions to lidocaine, those who have participated in another clinical trial within the last 30 days, people with significant medical conditions other than inflammatory bowel disease that might interfere with the study, and those unable to provide informed consent.

Study focus: The main goal is to determine if lidocaine can reduce pain intensity by at least 50% in patients with inflammatory bowel disease. The study will also examine how the treatment affects brain connectivity, comparing results between patients with inflammatory bowel disease and healthy volunteers. Researchers hope to gain insights into reducing background pain scores and decreasing episodes of increased pain sensitivity, which could lessen the psychological and social impacts of chronic pain.

Investigational drug: Lidocaine is administered through an intravenous infusion. It works at the molecular level by blocking sodium channels in nerve cells, which helps prevent the transmission of pain signals. The study aims to understand if this approach can offer meaningful relief for people with inflammatory bowel disease-related pain.

Study on the Effect of Levobupivacaine in Reducing Chronic Pain After Open Inguinal Hernia Repair in Patients

This trial focuses on preventing chronic pain that can develop after surgery to repair an inguinal hernia in the groin area. The study is investigating a pain management technique called the transversus abdominis plane (TAP) block, which uses a local anesthetic named levobupivacaine. Researchers want to find out if the timing of this block makes a difference in preventing long-term pain after surgery.

Who can participate: Adults over 18 years old who are scheduled for open inguinal hernia mesh repair using the Lichtenstein technique. Participants must have a symptomatic inguinal hernia confirmed by a doctor or imaging test. They need to be able to give written informed consent and have a health status classification of ASA I, II, or III, meaning they are either healthy, have mild systemic disease, or have severe systemic disease that is not life-threatening.

Who cannot participate: People who have not undergone open inguinal hernia mesh repair surgery, those who do not experience chronic postsurgical pain, patients outside the specified age range, and those who are part of a vulnerable population requiring special protection or care.

Study focus: The trial compares giving the TAP block before the surgical incision versus after the incision. Participants will be followed for three months after surgery to assess chronic pain levels using a questionnaire. The goal is to determine which timing provides better pain relief and reduces the need for long-term pain medications.

Investigational treatment: The ultrasound-guided TAP block is a type of regional anesthesia that numbs the nerves in the abdominal wall. Levobupivacaine, the medication used, works by blocking sodium channels in nerve cells to prevent pain signal transmission. It is classified as an amide-type local anesthetic.

Study Comparing Intravenous Contrast CT with Non-Contrast CT for Patients with Acute Abdominal Pain and Reduced Kidney Function Using Iohexol

This trial is designed for patients experiencing sudden and severe pain in the abdomen who also have reduced kidney function. The study compares two types of CT scans: one using an intravenous contrast agent called Omnipaque (which contains iohexol) and one without any contrast. The aim is to determine which approach provides better diagnostic information while considering the safety of patients with impaired kidneys.

Who can participate: Both men and women who need an emergency CT scan of the abdomen or body and have an eGFR (a measure of kidney function) between 15-45 ml/min/1.73 m2. This measurement must come from the most recent blood test for creatinine done within 24 hours before joining the study. Participants can be from vulnerable populations.

Who cannot participate: The trial has the same criteria as inclusion, meaning those who do not meet the specific kidney function requirements cannot participate.

Study focus: Researchers want to find out if using contrast-enhanced CT scans provides better diagnostic accuracy for acute abdominal conditions compared to non-contrast scans in patients with reduced kidney function. Participants will be randomly assigned to receive either type of scan and will be monitored for up to 90 days. The study will track overall survival, the need for kidney support treatments, changes in kidney function, and days spent out of the hospital.

Investigational agent: The intravenous contrast agent is a special dye given through a vein that helps doctors see internal organs and tissues more clearly on CT scans. It works by altering how X-rays interact with the body, providing clearer images. This diagnostic imaging agent is being studied to determine its safety and effectiveness in patients with compromised kidney function.

Summary

These three clinical trials represent different approaches to managing pain associated with various abdominal conditions. The first trial in Belgium focuses on chronic pain management in inflammatory bowel disease using lidocaine infusions. The second trial in Spain addresses the prevention of chronic pain following hernia surgery through carefully timed nerve blocks with levobupivacaine. The third trial, conducted across Finland and Norway, examines diagnostic imaging approaches for acute situations in patients with compromised kidney function.

Geographically, the trials are distributed across four European countries, with one trial spanning multiple Nordic countries. Each study addresses a distinct patient population and clinical scenario, from chronic inflammatory conditions to surgical pain prevention and emergency diagnostic procedures. The variety of interventions being tested, from anesthetic medications to imaging techniques, reflects the multifaceted nature of managing pain in different clinical contexts.

Ongoing Clinical Trials on Abdominal pain

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