J-Tip Use for Paracentesis in Adults With Ascites

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 Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Experimental J-Tip Needle-Free Injection System — 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) — 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

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 Dates

Start date

May 20, 2025

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Other: Control (25-gauge Needle) Arm, Current Standard of Care
  During abdominal paracentesis lidocaine will be administered superficially (intradermally) via a 25-gauge intradermal needle (control), as per the current standard of care.
• Experimental: Experimental (J-Tip device) Arm
  During abdominal paracentesis lidocaine will be administered superficially (intradermally) via needle-free injection system (the J-Tip device). This is the experimental arm to compare to the 25-gauge needle (standard of care) method of intradermal lidocaine administration during abdominal paracentesis.

Primary Outcome Measure

Pain during intra-dermal (superficial) local anesthetic administration [ Time Frame: From enrollment to end of procedure (approximately 2 hours). ]

Central Contacts

• Emily Kahn, MD
  (312) 926-5924
  [email protected]
• Christina Wing, BS
  (312) 926-0042
  [email protected]

Locations (1)

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