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

NCT06996379 | Recruiting FDA Device

• 1 other identifier: STU00222556
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 1.Pain during intra-dermal local anesthetic administration
2. 2.Pain during subcutaneous local anesthetic administration
3. 3.Pain during paracentesis
4. 4.Procedure-related anxiety

Conditions

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

Keywords

J-Tip; needle-less device; needle-free device; paracentesis; comfort; numbing; level of comfort; procedure-related pain

Outcome Measures

Primary Outcomes (3)

• Pain during intra-dermal (superficial) local anesthetic administration

  We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).

  From enrollment to end of procedure (approximately 2 hours).

• Pain during subcutaneous local anesthetic administration

  We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).

  From enrollment to end of procedure (approximately 2 hours).

• Pain during paracentesis

  We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).

  From enrollment to end of procedure (approximately 2 hours).

Secondary Outcomes (2)

• Anxiety about future procedures

  From enrollment to end of procedure (approximately 2 hours).

• Procedure related complications

  From enrollment to end of telephone follow-up survey (approximately 2 days).

Study Arms (2)

Control (25-gauge Needle) Arm, Current Standard of Care

OTHER

During abdominal paracentesis lidocaine will be administered superficially (intradermally) via a 25-gauge intradermal needle (control), as per the current standard of care.

Device: Control (Standard treatment)

Experimental (J-Tip device) Arm

EXPERIMENTAL

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.

Device: Experimental J-Tip Needle-Free Injection System

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.

Also known as: J-Tip, J-Tip device, J-Tip needle-less device, J-Tip needle-free device

Experimental (J-Tip device) Arm

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.

Also known as: control, 25-gauge needle

Control (25-gauge Needle) Arm, Current Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (5)

• Hajimaghsoudi M, Vahidi E, Momeni M, Arabinejhad A, Saeedi M. Comparison of local anesthetic effect of lidocaine by jet injection vs needle infiltration in lumbar puncture. Am J Emerg Med. 2016 Jul;34(7):1225-9. doi: 10.1016/j.ajem.2016.03.030. Epub 2016 Mar 16.

  PMID: 27055606 BACKGROUND

• Gozdemir M, Demircioglu RI, Karabayirli S, Sert H, Muslu B, Usta B, Yazici U. A Needle-Free Injection System (INJEX) with lidocaine for epidural needle insertion: A randomized controlled trial. Pak J Med Sci. 2016 May-Jun;32(3):756-61. doi: 10.12669/pjms.323.9174.

  PMID: 27375728 BACKGROUND

• Gursoy A, Ertugrul DT, Sahin M, Tutuncu NB, Demirer AN, Demirag NG. Needle-free delivery of lidocaine for reducing the pain associated with the fine-needle aspiration biopsy of thyroid nodules: time-saving and efficacious procedure. Thyroid. 2007 Apr;17(4):317-21. doi: 10.1089/thy.2006.0326.

  PMID: 17465861 BACKGROUND

• Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.

  PMID: 16384767 BACKGROUND

• Duncanson E, Le Leu RK, Shanahan L, Macauley L, Bennett PN, Weichula R, McDonald S, Burke ALJ, Collins KL, Chur-Hansen A, Jesudason S. The prevalence and evidence-based management of needle fear in adults with chronic disease: A scoping review. PLoS One. 2021 Jun 10;16(6):e0253048. doi: 10.1371/journal.pone.0253048. eCollection 2021.

  PMID: 34111207 BACKGROUND

Study Officials

• Emily Kahn, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Kahn, MD

CONTACT

(312) 926-5924; emily.kahn@nm.org

Christina Wing, BS

CONTACT

(312) 926-0042; christina.wing@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Upon enrollment, patients will be randomized using a randomization module built into the REDCap project, to either the control (25-gauge needle) or J-Tip arm. Patients will undergo diagnostic and/or therapeutic ultrasound-guided paracentesis as per standard of practice. The only difference between the groups will be the method of administering the superficial (intradermal) anesthesia. Based on randomization, lidocaine will be administered superficially via either 25 gauge intradermal needle (control) or the J-tip Needle-Free injection system. Following this superficial anesthesia injection, both groups will receive deeper subcutaneous lidocaine via a second 22-gauge needle per standard of care.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)