J-Tip for Topical Anesthesia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to make abdominal paracentesis (a procedure to remove fluid from the belly) less painful for individuals with liver cirrhosis and ascites. Instead of a needle to numb the skin, the trial uses a needle-free device called the J-Tip for topical anesthesia. Researchers aim to determine if this device can reduce pain and anxiety during the procedure. Participants must have cirrhosis and ascites, require a paracentesis, and be able to speak English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance comfort during medical procedures.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the J-Tip device is safe for use in paracentesis?
Research has shown that the J-Tip device is generally safe for people. In one study, using the J-Tip with lidocaine (a numbing medicine) reduced pain when placing an IV line in older children and teens. Another study found that when the J-Tip injected lidocaine, most participants felt very little pain, rating it less than 1 on a pain scale. The FDA has approved the J-Tip for use with lidocaine, confirming its safety for regular use.
No major reports of serious side effects with the J-Tip have emerged, suggesting it is well-tolerated and causes minimal discomfort. Overall, evidence indicates that the J-Tip provides a gentle and safe way to numb the skin without using a needle.12345Why are researchers excited about this trial?
Researchers are excited about the J-Tip device because it offers a needle-free way to administer lidocaine for pain relief during abdominal paracentesis. Unlike the standard 25-gauge needle method, the J-Tip uses a needle-free injection system, which could reduce the discomfort and anxiety often associated with needles. This innovative delivery method not only promises a more comfortable experience for patients but also maintains the effectiveness of lidocaine as an anesthetic.
What evidence suggests that the J-Tip device is effective for reducing pain during paracentesis in patients with cirrhosis?
This trial will compare the J-Tip device with the standard 25-gauge needle method for administering lidocaine during abdominal paracentesis. Studies have shown that the J-Tip device, which uses a needle-free method to deliver lidocaine, may help reduce pain during procedures. Research indicates that using the J-Tip for delivering lidocaine can be less painful than traditional needle injections. In one study, patients reported feeling less pain when the J-Tip was used for injecting lidocaine in conditions like trigger finger. This suggests that the J-Tip could make procedures like paracentesis more comfortable by reducing pain during numbing. Overall, the J-Tip is considered a promising option for those who want to avoid the pain of needle-based procedures.16789
Who Is on the Research Team?
Emily Kahn, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo abdominal paracentesis with either the J-Tip device or 25-gauge needle for local anesthetic administration
Follow-up
Participants are contacted to assess for procedure-related complications and pain
What Are the Treatments Tested in This Trial?
Interventions
- J-Tip
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor