Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
Northwestern University
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.
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 therapeut…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Adult (age \> 18 years) patients in the emergency department or admitted to the general medical service at Northwestern Memorial Hospital who: 1. Have cirrhosis and ascites 2. Require diagnostic and/or therapeutic paracentesis as determined by their primary physician 3. 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 t…
Interventions
- DeviceExperimental 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.
- DeviceControl (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.
Location
- Northwestern Memorial HospitalChicago, Illinois