J-Tip Use for Paracentesis in Adults With Ascites
Recruiting now · Not applicable
Conditions studied: Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin
In brief
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.
Key facts
- Study ID
- NCT06996379
- Run by
- Northwestern University
- People needed
- 110
- Starts
- 2025-05-20
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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