J-Tip Use for Paracentesis in Adults With Ascites

Official title

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

Overview

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.

Detailed description

The investigators would like to conduct an open label randomized control trial quantifying perception of pain during both administration of local anesthetic and during abdominal paracentesis when superficial (intradermal) lidocaine is administered via needle-free injection system as compared to via 25-gauge needle (standard of care). The study will include at least 110 participants in the emergency room or admitted to a general medical service with cirrhosis and ascites requiring bedside paracentesis, including both diagnostic (only a small sample of fluid removed for testing) and/or therapeutic paracentesis (a large amount of fluid removed to relieve discomfort). The primary physician caring for the patient will determine whether a paracentesis is required (not the study investigators).

Patients ≥ 18 years of age presenting to Northwestern Memorial Hospital with cirrhosis of the liver and ascites who require bedside paracentesis will be eligible for this study. Eligible patients will be identified by Emergency Department and Hospital Medicine providers who will notify study investigators. Upon identifying the patients and confirming eligibility through reviewing patients' charts and verbal screening questions, a study team member will approach patients, explain the study, and obtain written informed consent for those patients willing to participate. Patients whose preferred language is not English, those who have previously received or are currently receiving chemotherapy (as the J-Tip is contra-indicated in patients receiving chemotherapy), and those who are otherwise unable to provide informed consent will be excluded. Pregnant patients, prisoners, or other detained individuals will be excluded as well.

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.

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). Patients will also be asked about anticipated anxiety during future procedures. The thickness of skin tissue and tissue deep to the skin (subcutaneous tissue) overlying the ascites fluid in millimeters as measured by ultrasound will also be measured by the study investigators (Dr. Kahn or Dr. Barsuk) and recorded. Drs. Kahn and Barsuk are on the Hospital Medicine Procedure Service and are routinely consulted to perform paracentesis procedures on patients.

Two days following the procedure, a study member will contact the patient (in person or via phone) to inquire about complications including bleeding/bruising and pain following the procedure. Dr. Kahn will also chart review to assess for hemodynamically significant bleed or procedure related complication.

Interventions

• Device Experimental J-Tip Needle-Free Injection System
  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.
• Device Control (Standard treatment)
  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.

Primary outcome measures

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

Secondary outcome measures (2)

• Anxiety about future procedures [Time frame: From enrollment to end of procedure (approximately 2 hours).]
• Procedure related complications [Time frame: From enrollment to end of telephone follow-up survey (approximately 2 days).]

Eligibility criteria

Inclusion criteria

\- 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Northwestern Memorial Hospital — Chicago

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06996379 · STU00222556

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗