Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06996379

J-Tip Use for Paracentesis in Adults With Liver Cirrhosis and Ascites

Led by Northwestern University · Updated on 2025-05-30

110

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 abdominal paracentesis by numbing the skin with a needle-less device (the J-Tip), instead of using a needle to numb the skin. The main questions it aims to answer are the J-Tip effect upon: 1. Pain during intra-dermal local anesthetic administration 2. Pain during subcutaneous local anesthetic administration 3. Pain during paracentesis 4. Procedure-related anxiety Participants will be randomly assigned to have their skin numbed either in the usual way with a needle or with the J-Tip. Participants will be responsible for having a paracentesis done in their hospital room and answering the survey questions regarding pain experienced during the procedure and how they would feel if they needed to have this procedure performed again. There is also a telephone follow-up survey 2 days after the procedure to ask the participant about their experience post-procedure. We will also collect data about any procedure complications.

CONDITIONS

Official Title

J-Tip Use for Paracentesis in Adults With Liver Cirrhosis and Ascites

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged over 18 years
  • Diagnosed with cirrhosis and ascites
  • Require diagnostic and/or therapeutic bedside paracentesis as determined by their primary physician
  • Able to provide informed consent as judged by their emergency department or inpatient provider
  • Prefer English as their language for communication
Not Eligible

You will not qualify if you...

  • Have ever received chemotherapy treatment
  • Lack capacity to consent or to rate their pain using a numeric scale
  • Have contraindications to bedside paracentesis including unsafe procedure due to insufficient ascites or suboptimal fluid location
  • Have cellulitis over the planned site of fluid aspiration
  • Are pregnant
  • Do not prefer English as their language
  • Are prisoners

AI-Screening

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Trial Site Locations

Total: 1 location

1

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

E

Emily Kahn, MD

CONTACT

C

Christina Wing, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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