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Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the SkinSkinDevice

What this study is

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.

What's being tested

  • Experimental J-Tip Needle-Free Injection System

    Intervention · DEVICE

    This experimental intervention arm will include use of the J-Tip needle-less device to administer a one-time dose of 1% lidocaine during the superficial (intradermal) numbing step of a bedside abdominal paracentesis for adults with cirrhosis of the liver and ascites requiring bedside paracentesis.

  • Control (Standard treatment)

    Intervention · DEVICE

    The control intervention arm will include use of a 25-gauge needle (standard of care) to administer a one-time dose of 1% lidocaine during the superficial (intradermal) numbing step of a bedside abdominal paracentesis for adults with cirrhosis of the liver and ascites requiring bedside paracentesis.

Study details

Official title
Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
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
Enrolling
110 people
Starts
2025-05-20
Est. completion
2027-05
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗