Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the SkinNCT06996379
J-Tip Use for Paracentesis in Adults With Ascites
A study testing Experimental J-Tip Needle-Free Injection System in people with Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin
- What is being tested?
- Experimental J-Tip Needle-Free Injection System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Speak English as a preferred language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Emily Kahn, MD, (312) 926-5924, emily.kahn@nm.org
Christina Wing, BS, (312) 926-0042, christina.wing@northwestern.edu
About this study
Official title: Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
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:
- Pain during intra-dermal local anesthetic administration
- Pain during subcutaneous local anesthetic administration
- Pain during paracentesis
- 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.
Read the 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.
- Being tested
- Experimental J-Tip Needle-Free Injection System, Control (Standard treatment)
- Keywords
- J-Tip, needle-less device, needle-free device, paracentesis, comfort, numbing, level of comfort, procedure-related pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental J-Tip Needle-Free Injection SystemDevice
Also called J-Tip, J-Tip device, J-Tip needle-less device, J-Tip needle-free 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.
Control (Standard treatment)Device
Also called control, 25-gauge needle
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Experimental J-Tip Needle-Free Injection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: From enrollment to end of procedure (approximately 2 hours).
Secondary outcomes (2)
Anxiety about future procedures
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. Patients will be asked about anticipated anxiety during future procedures.
Measured: From enrollment to end of procedure (approximately 2 hours).
Procedure related complications
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. 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.
Measured: From enrollment to end of telephone follow-up survey (approximately 2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start20 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the SkinStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kahn, Northwestern University
- Investigators
- Emily Kahn, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996379
- Sponsor's protocol ID
- STU00222556
- Status last verified
- Jun 2026
- First submitted
- 21 May 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 27055606Gozdemir 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.
PubMed 27375728Gursoy 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.
PubMed 17465861Burns 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.
PubMed 16384767Duncanson 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.
PubMed 34111207
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
- ClinicalTrials.gov ID
- NCT06996379
- Acronym / sponsor ID
- STU00222556
- Keywords
- J-Tip, needle-less device, needle-free device, paracentesis, comfort, numbing, level of comfort, procedure-related pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pain during intra-dermal local anesthetic administration
- Pain during subcutaneous local anesthetic administration
- Pain during paracentesis
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control (25-gauge Needle) Arm, Current Standard of Care | Other | Device: Control (Standard treatment)During abdominal paracentesis lidocaine will be administered superficially (intradermally) via a 25-gauge intradermal needle (control), as per the current standard of care. |
| Experimental (J-Tip device) Arm | Experimental | Device: Experimental J-Tip Needle-Free Injection SystemDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Speak English as a preferred language
Key exclusion criteria (8 listed)
- 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:
- Do not speak English as a preferred language
- Are prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental J-Tip Needle-Free Injection SystemAlso: J-Tip, J-Tip device, J-Tip needle-less device, J-Tip needle-free deviceThis 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 | Experimental (J-Tip device) Arm |
| Control (Standard treatment)Also: control, 25-gauge needleThe 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. | Device | Control (25-gauge Needle) Arm, Current Standard of Care |
Primary outcome
Pain during intra-dermal (superficial) local anesthetic administration
Time frame: From enrollment to end of procedure (approximately 2 hours).
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).
Pain during subcutaneous local anesthetic administration
Time frame: From enrollment to end of procedure (approximately 2 hours).
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).
Pain during paracentesis
Time frame: From enrollment to end of procedure (approximately 2 hours).
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).
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 27055606Hajimaghsoudi 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.
- Background: PubMed 27375728Gozdemir 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.
- Background: PubMed 17465861Gursoy 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.
- Background: PubMed 16384767Burns 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.
- Background: PubMed 34111207Duncanson 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Kahn, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental J-Tip Needle-Free Injection System in people with Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Kahn, MD ((312) 926-5924, emily.kahn@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during intra-dermal (superficial) local anesthetic administration (time frame: From enrollment to end of procedure (approximately 2 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996379, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.