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Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ \- 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

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Emily Kahn, MD
emily.kahn@nm.org
(312) 926-5924
Backup
Christina Wing, BS
christina.wing@northwestern.edu
(312) 926-0042
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2027-05
Participants
Target number of participants: 110
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov