J-Tip for Topical Anesthesia

Overseen By Christina Wing, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Chemotherapy, Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Approximately 2 hours

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Emily Kahn, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults with liver cirrhosis and ascites who are at Northwestern Memorial Hospital. They must be scheduled for a bedside abdominal paracentesis and willing to answer survey questions about their pain and anxiety levels during the procedure.

Inclusion Criteria

I prefer to communicate in English.

I have cirrhosis and ascites and am either in the emergency department or admitted to Northwestern Memorial Hospital.

I need a procedure to remove fluid from my abdomen as decided by my doctor.

Exclusion Criteria

Patients who do not speak English as a preferred language

Prisoners

I have never received chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo abdominal paracentesis with either the J-Tip device or 25-gauge needle for local anesthetic administration

Approximately 2 hours

1 visit (in-person)

Follow-up

Participants are contacted to assess for procedure-related complications and pain

2 days

1 visit (phone)

Treatment Details

Interventions

• J-Tip

Trial Overview The study compares two methods of numbing the skin before paracentesis: traditional needle anesthesia versus a needle-free system called J-Tip. It aims to assess differences in pain, comfort, and anxiety during the procedure.

Participant Groups

Group I: Experimental (J-Tip device) Arm Experimental Treatment 1 Intervention

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.

Group II: Control (25-gauge Needle) Arm, Current Standard of Care Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+