Status:
RECRUITING
J-Tip Use for Paracentesis in Adults With Liver Cirrhosis and Ascites
Lead Sponsor:
Northwestern University
Conditions:
Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to evaluate the level of comfort adult patients with cirrhosis of the liver and ascites presenting to Northwestern Memorial Hospital experience during a bedside a...
Detailed Description
The investigators would like to conduct an open label randomized control trial quantifying perception of pain during both administration of local anesthetic and during abdominal paracentesis when supe...
Eligibility Criteria
Inclusion
- \- Adult (age \> 18 years) patients in the emergency department or admitted to the general medical service at Northwestern Memorial Hospital who:
- Have cirrhosis and ascites
- Require diagnostic and/or therapeutic paracentesis as determined by their primary physician
- Have capacity as determined by their ED or inpatient provider to consent for the procedure
- c. Speak English as a preferred language
Exclusion
- 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:
- Procedure deemed unsafe due to insufficient ascites/suboptimal location of ascites as evaluated by ultrasound
- Cellulitis overlying the site of aspiration
- Pregnancy
- Do not speak English as a preferred language
- Are prisoners
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06996379
Start Date
May 20 2025
End Date
May 1 2027
Last Update
May 30 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611