Using a needle-free device for numbing skin during paracentesis in liver cirrhosis patients
Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
NA · Northwestern University · NCT06996379
This study is testing a needle-free device to see if it can make the skin numbing process more comfortable for adults with liver cirrhosis who need a procedure to remove fluid from their abdomen.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06996379 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the comfort level of adult patients with liver cirrhosis and ascites during abdominal paracentesis when using a needle-less device (J-Tip) for numbing the skin, compared to the traditional needle method. Participants will be randomly assigned to receive either the J-Tip or standard needle-based local anesthetic before the procedure. The study aims to assess pain levels during the administration of local anesthetics and the paracentesis itself, as well as any procedure-related anxiety. A follow-up survey will be conducted two days post-procedure to gather additional feedback on patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with cirrhosis and ascites requiring bedside paracentesis.
Not a fit: Patients who have received chemotherapy or have contraindications to paracentesis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety for patients undergoing paracentesis.
How similar studies have performed: While the use of needle-free devices is gaining interest, this specific application in paracentesis has not been widely tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult (age \> 18 years) patients in the emergency department or admitted to the general medical service at Northwestern Memorial Hospital who: 1. Have cirrhosis and ascites 2. Require diagnostic and/or therapeutic paracentesis as determined by their primary physician 3. Have capacity as determined by their ED or inpatient provider to consent for the procedure c. Speak English as a preferred language Exclusion Criteria: * Have ever received chemotherapy, as this is a contra-indication to J-Tip use * Lack capacity to consent for the procedure and/or capacity to rate their pain using the numeric pain rating scale * Have a contraindication to bedside paracentesis, including: 1. Procedure deemed unsafe due to insufficient ascites/suboptimal location of ascites as evaluated by ultrasound 2. Cellulitis overlying the site of aspiration 3. Pregnancy * Do not speak English as a preferred language * Are prisoners
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Emily Kahn, MD — Northwestern University
- Study coordinator: Emily Kahn, MD
- Email: emily.kahn@nm.org
- Phone: (312) 926-5924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin, J-Tip, needle-less device, needle-free device, paracentesis, comfort, numbing, level of comfort