Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
Phase: NA
Conditions: Knee Injury
Sponsor: Orlando Health, Inc.

Randomized Controlled Trial of Needleless Jet 
Injected (J-Tip) Lidocaine in Children 
Undergoing Regional Anesthesia Prior to Knee 
Arthroscopy 
NCT02649322 
August 28, 2019

 
- 1 -
Generated on IRBNet
 
   1414 Kuhl Ave.
 
 
   Orlando, FL 32806
FWA # 00000384
 
   321.843.7000
 
 
   orlandohealth.com
 
 
 
 
 
 
 
 
 
 
DATE:
August 28, 2019
 
 
TO:
Daryl Osbahr, MD
FROM:
Orlando Health IRB #2
 
 
PROJECT TITLE:
[747969-9] Randomized, Controlled Trial of Needleless Jet Injected (J-
Tip) Lidocaine in Children Undergoing Regional Anesthesia prior to knee
arthroscopy.
REFERENCE #:
14.099.08
SUBMISSION TYPE:
Closure/Final Report
 
 
ACTION:
TERMINATED
APPROVAL DATE:
August 28, 2019
REVIEW TYPE:
Expedited Review
 
 
Thank you for your submission of Closure/Final Report materials for this project. The submission was
reviewed and approved by the Orlando Health IRB #2.
Study records must be maintained in a secure location. For the length of time the records must be stored,
follow any applicable regulations/policies from Orlando Health, the state of Florida, and the federal
government, as well as any requirements the study sponsor might have.
If you have any questions, please contact the IRB Office at (321) 841-5895. Please include your project
title and reference number in all correspondence with this committee.
 
 
This letter has been electronically signed in accordance with all applicable regulations, and a copy is retained within Orlando Health
IRB #2's records.

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Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine 
in Children Undergoing Regional Anesthesia prior to knee arthroscopy. 
 
 
Principal Investigator: 
Daryl Osbahr, MD 
Department of Sports Medicine 
Level One Orthopaedics 
1222 South Orange Avenue 
Orlando, FL. 32828 
321-843-5851 
 
Sub - Investigators: 
Mario Zelaya, MD 
Stephanie King, ARNP 
Arnold Palmer Hospital Anesthesia Department 
92 W Miller St, Orlando, FL 32806 
407-649-9111 
 
Research Assistant: 
Christopher Mancini 
Orlando Health 
1400 S. Orange Ave. Orlando, FL 32806 
Tel: 321.841.7178 
321.841.7178 
 
Regulatory Coordinators: Ibrahim M. Zeini, PhD, PMP, CCRP 
Elizabeth Ford, BS 
Department of Sports Medicine 
Level One Orthopaedics 
1222 South Orange Avenue 
Orlando, FL. 32828 
321-841-3867 
 
Study Sites 
Arnold Palmer Hospital 
Level One Orthopaedics 
Orlando Health, INC 
Department of Sports Medicine 
1222 South Orange Avenue 
Orlando, FL. 32806 
321-841-5851 
 
Study Product: 
J-Tip Needleless Injection System  
IRB Number: 
14.099.08 
Initial version:  
       September 2, 2015 
 
 
        December 14, 2015 
 
 
       July 19, 2016 
 
 
        July 14, 2017 
 
 
        June 6, 2018 
 
 

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Table of Contents: 
 
1. 
Research Synopsis 
1.1 
Study Title………….…………………………………………………….5 
1.2 
Study Population.…………………………………………………….….5 
1.3 
Study Design………………………………………………………..…….5 
1.4 
Sample Size……………………………………………………………….5 
1.5 
Study Duration…………………………………………………………...5 
1.6 
Primary Objective….……………………………………………………5 
1.7 
Secondary Objectives…………………………………………………....5 
2. 
Background and Significance……………………………….……………..6 
3. 
Objectives………………………………………………………….……..……..7 
3.1 
Primary Objective…….………………………………………………….7 
3.2 
Secondary Objectives….…………………………………...…………....7 
4. 
Study design/methodology…………………...………………...…………...7 
5. 
Study Population…………………………………………….…...………….10 
 
5.1 
Inclusion /Exclusion Criteria…………………………………………..10 
6. 
Study Duration/ Study Timeline…………………………………..…….10 
7. 
Statistical Analysis Plan……………………………………………..…….10 
8. 
Informed Consent Process…………………………………………..…….10 
9.  
Privacy and confidentiality ………………………...……………..…..…....11 
10. 
Risk/Benefit……………………………………………………………..…….11 
 
10.1 
Risk(s) to Participants………………………….………………..……..11 
10.2 
Benefits(s) to Participants…………………………...…………..……..11 
11. 
Data Safety Monitoring……………………………….……………..…….11 
12. 
Conflict of Interest…………………………….…………….….……...……11 
13. 
Publication and Presentation Plans………………...……………..…….11 
14. 
References……………………………………………………………….…….11 
15. 
Appendices  
 
 
“Nervous” Visual Analogue Scale (VAS) 
  Pain Visual Analogue Scales (VAS) 
 Arthroscopic Surgery Satisfaction Questionnaire Parent (J-Tip) 
 Arthroscopic Surgery Satisfaction Questionnaire Child (J-Tip) 
Arthroscopic Surgery Satisfaction Questionnaire Parent (Needle) 
 Arthroscopic Surgery Satisfaction Questionnaire Child (Needle) 
 Home medication logs 
 
 
 
 
 
 
 
 
 

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List of Abbreviations: 
 
VAS=Visual Analog Scale 
FNB=Femoral Nerve Block 
SNB=Sciatic Nerve Block 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. 
Research Synopsis  
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for 
pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional 
anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic 
knee surgery compared to femoral nerve block and/or sciatic nerve block with needle 
injected lidocaine prior to regional and general anesthesia. 
 
1.1 
Study Title 
Randomized Prospective Trial of Needleless Jet Injected (J-Tip) Lidocaine in 
Children Undergoing Regional Block Anesthesia prior to knee arthroscopy. 
 
1.2 
Study Population 
Children of both sexes, between the ages of 11 and 17 undergoing arthroscopic knee 
surgery will be eligible for this study.  
 
1.3 
Study Design 
This study is a prospective and randomized project. 
 
1.4 
Sample Size 
A sample size of 50 per group, two groups, for a total of 100 patients is the goal. An 
additional 15 patients will be enrolled to account for withdrawals, bringing total enrolled 
to 115.  
1.5 
Study Duration 
This study is estimated to take 3 years to complete, including the length of time to review 
charts, data collection, and analysis of study data. 
 
1.6 
Primary Objective 
The primary objective is to measure the change in pain from a femoral or sciatic nerve 
block with the use of J-tip injected lidocaine compared to needle injected lidocaine for 
local anesthesia prior to the regional nerve block. 
  
1.7 
Secondary Objectives 
 To evaluate the difference in pain from local anesthetic infiltration with J-tip 
needleless injection compared to needle injection. 
 To evaluate efficacy of femoral and/or sciatic nerve block after J-tip lidocaine 
injection compared to needle injected lidocaine post operatively by tracking pain 
levels to post operative day three. 
 To assess patient and parent satisfaction with J-tip use. 
 To assess changes in post operative pain medication amounts with J-tip use. 
 To evaluate changes in post operative nausea and/or vomiting with J-tip use. 
 To evaluate changes in post operative anti-nausea/anti-emetic mediation use with 
J-tip use. 
 To evaluate changes in time of PACU stay. 

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 To assess any differences in outcomes or pain after J-tip or needle injected 
lidocaine with respect to BMI, thigh circumference, gender, ethnicity or operative 
time in pain reporting measures, satisfaction or medication usage. 
 
2. 
Background and Significance: 
Lower extremity regional nerve block anesthesia has been shown to decrease post-
operative pain and length of hospital stay after arthroscopic knee surgery (Nowicki, 
Micalizzi, Schloss). The introduction of the nerve block needle is still a source of pain 
and anxiety for the pediatric patient. The pain experienced during the nerve block 
procedure may cause difficulty in technique allowing for the most efficient nerve 
blockade. Infiltration of the subcutaneous tissues with local anesthetic is usually 
performed prior to nerve block needle introduction. This is performed by standard 
techniques with needle and syringe and is associated with the pain usually experienced 
with one or more needle sticks required to fully deposit the local anesthetic. It has also 
been suggested that post block complications are higher in pediatric patients receiving 
nerve blocks while awake or sedated compared to patients already under general 
anesthesia (Taenzer).  For this and other reasons, many of these blocks are performed 
with the patient already in the operating room under a general anesthetic. This can 
increase operating room time and expense for each surgical case 
 
Patients have benefited from the increasing use of lower extremity regional block 
anesthesia for arthroscopic knee surgeries. This benefit has been realized by patients with 
regard to decreased pain post operatively. The health care system and patients share the 
benefit of decreased length of hospital stay and significantly fewer patients admitted to 
inpatient status. Current practices with anesthesia for pediatric patients undergoing knee 
surgery is variable. General anesthesia is the norm during arthroscopic knee surgery, but 
the introduction and timing of regional blocks is physician and institution dependent. In 
some cases femoral and sciatic blocks are used and in others only femoral blocks are 
used.  Some are introduced prior to leaving the preoperative area, after general anesthesia 
has been administered, while still under general anesthesia after the procedure is 
complete, or in the post anesthesia care unit with the general anesthetic effects 
diminishing. Most blocks at Arnold Palmer medical center are administered in the 
preoperative area prior to patient transfer to the operating room. 
 
The J-tip has not been reported for use prior to regional block anesthesia prior to femoral 
or sciatic nerve blocks. The use of the J-tip for lidocaine introduction prior to femoral or 
sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of the 
anesthesiologist. It has been anecdotally reported at our institution to have equal or better 
pain relief for the regional nerve blocks as needle introduction of lidocaine. 
 
While there has been much attention appropriately directed to post operative pain control 
after arthroscopic surgery, minimal concern has been shown to decrease pain from 
regional block needle introduction. Needle insertion is the most common pain provoking 
procedure in the hospital setting. The American Academy of Pediatrics has addressed 
acute pain states with a policy statement expressing the need to anticipate, assess and 
manage pain caused by medical procedures. (AAP) There have been many advancements 

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to minimize the pain due to needle introduction for procedures such as venipuncture, 
intravenous cannulation and lumbar puncture (Ferayorni). It has been shown that 
anesthetic introduction by eutetic mixture of local anesthetics (EMLA) cream or 
needleless jet injection of local anesthetic reduces reported and observed pain and anxiety 
score validated measures when used prior to these procedures. There has been a 
demonstrated advantage in time to anesthesia and pain relief with needleless jet injection 
of lidocaine compared to EMLA cream use prior to venipuncture (Jimenez, Spanos, 
Zsigmond IJCPT 99). A decrease in pain has also been shown with jet-injected lidocaine 
over jet-injected placebo prior to needle insertions (Auerbach, Peter, Zsigmond JCA 99). 
 
Limiting the use of pain medications and thus their potential side effects is becoming a 
greater point of emphasis in medicine. The use of opiate based medication to control 
acute pain from orthopaedic surgery is common. Utilization of these medications comes 
with possible pitfalls ranging from physiologic side effects to addiction. The most 
common side effects are manifested as nausea and vomiting. Control of these side effects 
often requires the administration of another pharmacologic agent. Within the field of 
orthopaedics, the use of regional block anesthesia prior to arthroscopic knee surgery has 
shown to decrease post-operative pain. This has lead to decreased opioid requirements. In 
turn this could provide for fewer medication-related side effects (Schloss). Local 
anesthesia prior to regional blockade may allow for a more effective block and permit the 
use of fewer pain medications and occurrence of side effects for those medications. 
 
3. 
Objectives: 
 
3.1 
Primary Objective 
The primary objective is to measure the change in pain from femoral and/or sciatic nerve 
block with the use of the J-tip injector by visual analogue scales (VAS) for pain 
reporting. 
 
3.2 
Secondary Objectives 
 To evaluate the difference in pain from local anesthetic infiltration with J-tip 
needleless injection compared to needle injection by use of VAS. 
 To evaluate efficacy of femoral nerve block after J-tip lidocaine injection post 
operatively by use of VAS. 
 To assess patient and parent satisfaction with J-tip use by satisfaction 
questionnaire. 
 To assess changes in post operative pain medication amounts with J-tip use. 
o 1)Type and amount in PACU 
o 2) Home log of amount taken daily for post operative days one through 
three (Standard opiate based pain medication prescription given to each 
patient). Measured in number of pills/tablets taken each day. 
 To evaluate changes in post operative nausea and/or vomiting with J-tip use. 
o Calculated as “Present” or “Absent” 
 To evaluate changes in post operative anti-nausea/anti-emetic mediation use with 
J-tip use. 
o 1)Type and amount in PACU 

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o 2) Home record log of amount taken daily (Standard medication 
prescription given to each patient). Measured in number of pills/tablets 
taken each day. 
 To evaluate time in PACU with use of J-tip compared to needle use group prior to 
regional block. PACU stay time recorded in minutes.  
 
 
4. 
Study design/methodology: 
 
This study will be submitted to the Institutional Review Board of Orlando Health in 
Orlando, Florida, and will be conducted at Arnold Palmer Hospital from June 2015 to 
September 2017. Patients’ age 11-17 years old undergoing knee arthroscopies are eligible 
for the trial. A single surgeon will perform all arthroscopic knee surgeries in this study. A 
femoral and/or sciatic block will be performed prior to the knee arthroscopic surgery. A 
single anesthesiologist will perform all J-tip or needle local anesthesia injections and 
nerve blocks in this study. Written consent is to be obtained from the parents or legal 
guardians, and written assent is to be obtained from the patients. The J-tip injector by 
National Medical Products, INC. will be used for needleless injection of 0.25 mL of 1% 
plain lidocaine or 1.5 mL of 1% plain lidocaine will be injected by syringe and 25-gauge 
needle into the subcutaneous tissues of the proximal anterior thigh near the inguinal 
crease prior to the femoral nerve block and the proximal posterolateral thigh near the 
gluteal fold or the posterolateral thigh prior to the sciatic regional nerve block. The 
location for the sciatic regional block along the course of the nerve will be chosen at the 
discretion of the performing anesthesiologist as is customary for sciatic nerve block 
procedures. 
 
Patients with a known allergy to lidocaine, preoperative analgesic treatment with 
medications other than nonsteroidal anti-inflammatory drugs and acetaminophen, current 
use of chemotherapeutic agents, coagulation disturbance affecting coagulation abilities, 
any signs of skin infection or pathology at the injection site, neurosensory deficit at area 
of injection, developmental delay diagnosis precluding pain scale completion, and 
patients who received any other local anesthesia in the area of the regional block needle 
introduction prior to the regional block procedures will meet the exclusion criteria for this 
trial. 
 
The J-tip will not be used for any IV insertions on patients in this study. There is 
currently variable use of the J-tip prior to IV insertions currently at Arnold Palmer 
Medical Center. 
 
Demographics and anthropometric measurements considered in this study will be age, 
gender, ethnicity, thigh circumference and body mass index (BMI). Thigh circumference 
on the surgical side will be measured as 1/3 the distance distal to the ASIS to the superior 
pole of the ipsilateral patella. 
 
Randomization to form the two trial groups will be performed by utilizing the computer 
program ‘Research Randomizer’ to create the randomization list. Randomization will be 
50/50 or 1 to1. The assignments will be printed out and placed into numbered envelopes. 

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The envelopes will be kept in a box in the Dr. Zelaya’s office. Group 1 will receive 0.25 
mL of 1% buffered lidocaine delivered by the J-tip injector. Group 2 will be formed by 
subjects receiving 1.5 mL of 1% plain lidocaine injected by syringe and 25 gauge needle. 
The site of administration for this trial will be standard femoral and/or sciatic nerve block 
locations. The regional block will be performed under ultrasound guidance and with the 
assistance of nerve stimulation. General anesthesia will be given when the patient is in 
the operating room. This is done after the regional blocks have already been completed. 
 
Administration of sedative and anxiolytic medications before or during the regional nerve 
block procedures will be based on nervous and pain VAS scores and anesthesiologist 
graded anxiety scores. If anxiety levels are indicated to be less than four, no sedation will 
be administered prior to the nerve block procedure. If anxiety scores are four to seven, 
then two mg to a maximum of four mg of versed IV will be administered just prior to the 
local anesthesia administration. If anxiety scores are greater than seven, then two mg to a 
maximum of four mg of IV Versed will be administered just prior to the local anesthesia 
administration. If anesthesiologist observed anxiety levels remain above 7, then 20 mcg 
to a max of 40 mcg of IV Precedex will subsequently be administered.  
 
The current observations of clinical efficacy in the delivery of local anesthesia by either 
needle or J-tip introduction have shown that the superficial and subcutaneous tissues are 
adequately anesthetized. Pain is usually encountered as the touhy needle, nerve block 
needle, penetrates the fascia of the muscle. The fascia is a barrier to the deeper tissues 
and is not anesthetized with any local anesthetic. Additional medications may be 
administered during the needle insertion through the fascia during the regional block. If 
pain VAS is greater than four, and IV Versed was not administered due to anxiety scores 
between four and seven, then two mg to a maximum of four mg of IV Versed will be 
administered. If pain continues to be above four and IV Precedex was not administered 
due to anxiety levels greater than seven, then 20 mcg to a max of 40 mcg IV Precedex 
will be administered. If pain continues to be greater than four, then 25 mcg Fentanyl to a 
maximum of 50 mcg will be administered. If pain values continue to be above seven, 
then 100 mg of IV propofol will be given. No matter what amount and type of sedative or 
anxiolytic is administered during the nerve block procedure, the first VAS measure at 
each time point will be the one of record for analysis in this study. 
 
Patients will indicate their level of nervousness by completing a visual analogue scale, 
after admission to the preoperative area, for how nervous they are prior to their 
procedure. The anesthesiologist through observational measurement on a scale of 0-10 
will also measure patient anxiety levels. A level of ten will be the highest observed 
measure of anxiety. These scores will assist in identifying patients that may need more 
general types of anesthesia prior to the nerve block. This will also allow for further 
evaluation of limitations due to the amount of pre-op anesthesia of patients in the study. 
 
Femoral nerve blocks will be performed on all arthroscopic procedures. Single injection 
sciatic nerve blocks will be utilized in addition to femoral catheter nerve blocks for 
patients undergoing arthroscopic surgery with ACL reconstruction or if lateral meniscus 
repair is expected to be performed. The site or sites of injection on the operative lower 
extremity will be chosen, a timeout taken and sterile preparation performed by the 

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anesthesiologist prior to local anesthetic infiltration and the regional blockage needle 
introduction. After sterile preparation, the J-tip injector will be placed on the skin at the 
selected site of the regional block needle introduction. Firm pressure will be placed with 
the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger 
pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of 
one percent lidocaine will be injected with the characteristic “pop” and “hissing” sounds 
inherent to the J-tip injector. There is the possibility of medication leak and spray from 
under the J-tip. This is known to happen with use of the device and can be minimized 
with firm pressure of the device on the skin. Ninety seconds after the J-tip discharge, the 
regional block will be administered. The same initial timeout and sterile prep procedure 
will be followed for the use of local syringe and 25 gauge needle injection of 1% 
lidocaine ninety seconds prior to introduction of the regional block needle. The parents 
will be out of the room to reduce any effect on pain levels they could have by contact 
with the patient. Having the parents outside of the room is currently the standard during 
nerve block procedures at Arnold Palmer Hospital. No music, television, or video screen 
will be allowed to be on in the room from the time of the timeout to the completion of the 
post nerve block VAS completion to minimize confounders that could alter pain 
perception. Currently, there is no specific attention paid to whether or not music, 
television, or video screen is on during the procedure. There is varied and inconsistent 
use at this time.. If the sciatic regional block needle introduction is felt by the 
anesthesiologist to be an inadequate location, the procedure of local anesthesia and VAS 
questionnaires will be restarted and completed again for a new location. The new location 
will be at least two centimeters from the previous location. This will take into effect the 
local tissue dispersion of lidocaine shown to be about 1.8cm in diameter in previous 
needless injector studies (Hardison, Bennett). National Medical Products, INC. describes 
the dispersion of the medication delivered by the J-tip to usually be the size of the front 
diameter of the J-tip device, which measures one centimeter. The number of attempts 
with needle sticks for the regional block needle will be recorded for further analysis. 
 
Times will be recorded for; time of J-tip administration, time of regional block 
performance, operating room arrival time, incision time, surgical end time, PACU arrival 
time and PACU discharge time. The amount of time from regional block to arrival in 
operating room and to incision time will be calculated. The surgical procedure time and 
amount of time in PACU will also be calculated. 
 
Visual analogue pain scales will be completed prior to and immediately after J-tip use or 
needle local anesthesia infiltration. The scale immediately after will be with regard to 
pain felt at time of J-tip use or needle introduction. The scale will be completed once 
again prior to and immediately after needle introduction for each regional blockade. The 
scale immediately after will be with regard to pain felt at time of regional block needle 
introduction. Visual analogue pain scale will be recorded in PACU. All scoring will be 
performed on separate VAS assessments without patient access to previous scores. 
 
The patient will record visual analogue pain scales on post-operative days one through 
three. The anesthesiologist will collect telephone verbal pain scores on a 0-10 scale on 
post-operative days one and two. This is current standard procedure for all patients who 

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receive a regional block. The femoral nerve block catheter, when utilized, is left in place 
for 40 hours from the initial femoral nerve block procedure. The number of days until the 
post-operative visit will be recorded. Another visual analogue pain scale will be 
completed at the first post-operative visit. An Arthroscopic Surgery Satisfaction 
Questionnaire will be completed by the patient and a parent or guardian at the first post-
operative visit. The questionnaire will be specific to the patient’s randomized treatment 
group. If the patient was randomized to receive the J-Tip, the patient and parent will 
receive the J-Tip questionnaire and if the patient was randomized to receive the 
traditional needle and syringe, the patient and parent will receive the needled syringe 
questionnaire.  The sex of the parent or guardian completing the form will be recorded. 
 
It will also be recorded if intra-articular analgesic injection is given intra-operatively. The 
amount and type of pain and anti-nausea/emetic and pain medication use will be recorded 
in PACU and by the patient on the first three post-operative days. 
 
5. 
Study Population: 
The 15 patients enrolled to account for withdrawals will cover patients who wish to self-
select to the J-tip or needle group and do not wish to be randomized. These patients will 
not be in the final analysis. Patients who wish to switch groups after being randomized 
will be allowed to switch, but will be withdrawn from final analysis. If a patient does not 
wish to have either method of local anesthesia delivery prior to the regional block, they 
will be withdrawn from final analysis. 
 
 
5.1 
Inclusion /Exclusion Criteria 
Inclusion:   
 Subjects between the ages of 11 and 17 undergoing arthroscopic 
knee surgery. 
 Able to independently complete the VAS pain scales. 
 Subjects who are neurologically intact at area of injection. 
 English speaking. 
 
Exclusion: 
 Subjects with known allergies to lidocaine. 
 Presence of developmental delay. 
 Subjects with blood disorders affecting coagulation. 
 Subjects on blood thinners. 
 Subjects receiving chemotherapeutic agents. 
 Those who use or receive analgesia prior to procedure, except for 
acetaminophen or NSAIDs.  
 Any other local sedation at the area of nerve block injection. 
 *Non-English Speaking 
 Subjects with signs of skin infection or pathology at the injection 
site. 
 
*The consent form and other documents for this study are not available in any 
other language. Non-English speaking families may not fully understand the study. 

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6. 
Study Duration/ Study Timeline:  
 
Stage 1, enrollment of patients: 12 to 24 months. 
Stage 2, data collection and data analysis: 3-6 months. 
Stage 3, presentation and publication: 6-12 months. 
Goal is to conclude data analysis by: September 2017 
 
 
7. 
Statistical Analysis Plan: 
Analyses will vary by specific aim. To evaluate our hypotheses, we will use exact and 
non-parametric hypothesis testing procedures. Confidence intervals (95%) of differences 
will be computed.  Regression analysis will be employed when adjustment between 
comparison groups is considered necessary.  
 
8. 
Informed Consent Process: 
IRB approval will be obtained prior to patient recruitment.  Patients will be identified as 
they present to the orthopaedic pediatric service of Arnold Palmer Hospital / Orlando 
Health Inc. with a qualifying injury to determine their interest in participating in the 
study.  The study will be explained to them, they will have an opportunity to read the 
consent, have their questions answered.  If they agree to participate, they will be 
randomized to a treatment arm as described above. 
 
9. 
Privacy and Confidentiality: 
Any PHI will be kept on a password protected database and will be linked only with a 
study identification number for this research. All data will be entered into a computer that 
is password protected. Data will be stored in a locked office of the investigators and 
maintained for a minimum of five years after the completion of the study. 
 
10. 
Risk/Benefit: 
10.1 
Possible Risk to participants: 
 
 Allergic reaction to lidocaine with a previously unknown allergy. 
 Blood reflux at injection point. 
 Skin wheal. 
 Skin bruising. 
 
10.2 
Possible Benefits to Participants 
 
 Decreased pain from local anesthesia infiltration compared to needle injected 
local anesthetic at nerve block site. 
 Decreased pain during femoral and/or sciatic nerve block procedure.  
 Possible increased efficacy of femoral nerve block leading to decreased post-
operative pain, medication use and pharmacologic side effects. 
 

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11. 
Data Safety Monitoring: 
Monitoring is an ongoing review of the study throughout its duration. 
Safeguards to protect research participant data and identity include but are not limited to 
restricting access to data to the principal, sub investigators and the study coordinators. 
Identifiable PHI will not be used in any manuscript and any data containing PHI will be 
stored in a password protected computer.  
 
12. 
Conflict of Interest: 
This is not a sponsored study. There is no additional benefit to the investigator(s) beyond 
academic publication or presentation. No direct financial support for the study will be 
provided from any entity.  No royalties will be received from any implants implanted at 
Orlando Health. 
 
13. 
Publication and Presentation Plans: 
This project will be presented at Orthopaedic meetings and the manuscript is to be 
presented for publication in a peer reviewed Orthopaedic journal. 
 
14. 
References: 
American Academy of Pediatrics. Committee on Psychosocial Aspects of Child and 
Family Health. The Assessment and Management of Acute Pain in Infants, Children, and 
Adolescents (0793). Pediatrics. 2001; Vol 108, No. 3 793-797, September. 
 
Auerbach, M, Tunik M, Mojica M. A Randomized, Double-blind Controlled Study of Jet 
Lidocaine Compared to Jet Plecebo for Pain Relief in Children Undergoing Needle 
Insertion in the Emergency Department. Acad Emerg Med. 2009;Vol 16, No. 5. 388-393. 
 
Bennett, CR, Mundell, RD, Monheim, LM, et al. Studies on tissue penetration 
characteristics produced by jet injection. Journal Am Dent Assoc. 83:501, 1974. 
 
Ferayorni, A, Yniguez, R, Bryson, M, et al. Needle-Free Jet Injection of Lidocaine for 
Local Anesthesia During Lumbar Puncture. A Randomized Controlled Trial. Pediatric 
Emergency Care. 2012; Volume 28, No. 7, July. 687-690. 
 
Hardison, CD. Application of a Versatile Instrument for Production of Cutaneous 
Anesthesia Without Needle Penetration of the Skin. JACEP 6: 266-268, June 1977. 
 
Jimenez, N, Bradford, H, Seidel KD, et al. A Comparison of a Needle-Free Injection 
System for Local Anesthesia Versus EMLA for Intravenous Catheter Insertion in the 
Pediatric Patient. Anesth Analg. 2006; 102; 411-414 
 
Micalizzi RA, Williams LA, Pignataro, S, et al. Review of Outcomes in Pediatric Patients 
Undergoing Anterior Cruciate Ligament Repairs With Regional Nerve Blocks. J of 
Pediatric Nursing. 2014. 
 

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Mulroy MF, Larkin KL, Batra MS, et al. Femoral nerve block with 0.25% or 0.5% 
bupivacaine improves postoperative analgesia following outpatient arthroscopic anterior 
cruciate ligament repair.  Reg Anesth Pain Med. 2001;26:24-29. 
 
Nowicki, PD, Vanderhave, KL, Gibbons, K, et al. Perioperative Pain Control in Pediatric 
Patients Undergoing Orthopaedic Surgery. 2012; Journal of the American Academy of 
Orthopaedic Surgeons. Volume 20, No. 12 December. 
 
Patel NJ, Flashburg MH, Paskin S, et al. A regional anesthetic technique compared to 
general anesthesia for outpatient knee arthroscopy. Anesth Analg. 1986;65 185-187. 
 
Peter, DJ, Scott, JP, Watkins, HC, et al. Subcutaneous Lidocaine Delivered by Jet-
Injector for Pain Control Before IV Catheterization in the ED: The Patients’ Perception 
and Preference. American Jounal of Emergency Medicine. 2002; Volume 20, No. 6, 
October. 
 
Schloss B, Bhalla T, Klingele, K, et al. A Retrospective Review of Femoral Nerve Block 
for Postoperative Analgesia After Knee Surgery in the Pediatric Population. J Pediatr 
Orthop. 2014;34 459-461. 
 
Spanos, S, Booth, R, Koenig, H, et al. Jet Injection of 1% Buffered Lidocaine Versus 
Topical ELA-Max for Anesthesia Before Peripheral Intravenous Catheterization in 
Children. A Randomized Controlled Trial. Pediatric Emergency Care. 2008; Volume 24, 
No. 8, August. 
 
Taenzer AH, Walker, BJ, Bosenber, AT, et al. Asleep Versus Awake: Does It Matter? 
Pediatric Regional Block Complications by Patient State: A Report From the Pediatric 
Regianla Anesthesia Network. Regional Anesthesia and Pain Medicine. 2014; Volume 
39, No. 4, July-August. 
 
Zsigmond, EK, Darby, P, Koenig, HM, et al. Painless Intravenous Catheterization by 
Intradermal Jet Injection of Lidocaine: A Randomized Trial. Journal of Clinical 
Anesthesia. 1999; 11:87-94, March. 
 
Zsigmond, EK, Darby, P, Koenig, HM, et al. A New Route, Jet Injection of Lidocaine for 
Skin Wheal for Painless Intravenous Catheterization. International Journal of Clinical 
Pharmacology and Therapeutics, 1999; Vol 37, No. 2 90-99. 
 
 
 
 
15. 
Appendices : 
“Nervous” Visual Analogue Scale (VAS) 
Pain Visual Analogue Scale (VAS) 
Arthroscopic Surgery Satisfaction Questionnaire Parent (J-Tip) 
Arthroscopic Surgery Satisfaction Questionnaire Child (J-Tip) 

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Arthroscopic Surgery Satisfaction Questionnaire Parent (Needle) 
Arthroscopic Surgery Satisfaction Questionnaire Child (Needle) 
Home medication logs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Results: 
Descriptive Statistics: Visual Analogy Scores (VAS) After Local Femoral and Local 
Sciatic Nerve Blocks 
As seen in Table 1, the mean VAS immediately after local femoral for is 1.54 with a 
standard deviation 1.524 and the mean VAS immediately after local femoral for Needle 
Injections is 3.57 with a standard deviation 2.133. The mean VAS immediately after local 
femoral for J-Tip injections is 2.03 less than the mean VAS immediately after local 
femoral for Needle Injections. The difference time shows a large time gap and variation 
between the two injection types.  
As seen in Table 1, the mean VAS immediately after local sciatic for is 2.272 with a 
standard deviation 2.1631 and the mean VAS immediately after local sciatic for Needle 
Injections is 4.5 with a standard deviation 2.4553. The mean VAS immediately after local 
sciatic for J-Tip injections is 2.228 less than the mean VAS immediately after local 
sciatic for Needle Injections. The difference time shows a large time gap and variation 
between the two injection types.  
 
Injection 
Type 
N 
Mean 
Standard 
Deviation 
Standard 
Error Mean 
VAS Immediately 
After Local Femoral 
Needle 
54 
3.57 
2.133 
.290 
J-Tip 
57 
1.54 
1.524 
.202 
VAS Immediately 
After Local Sciatic 
Needle 
54 
4.500 
2.4553 
.3341 
J-Tip 
57 
2.272 
2.1631 
.2865 
Table 1: Group Statistics 
 
 
 
Two-Sample T Test: Visual Analogy Scores (VAS) After Local Femoral and Local 
Sciatic Nerve Blocks 
VAS Immediately After Local Femoral: 
H0 : No statistically significant difference exists between the mean of the VAS 
Immediately After Local Femoral for Needle Injections and the mean of VAS 
Immediately After Local Femoral in the J-Tip Injections. 
 
Ha: A statistically significant difference exists between the mean of the VAS 
Immediately After Local Femoral for Needle Injections and the mean of VAS 
Immediately After Local Femoral in the J-Tip Injections. 
 
The VAS Immediately After Local Femoral for J-Tip Injections exceeds the mean VAS 
Immediately After Local Femoral for Needle Injections to a statistically significant 
degree, t(95.525) = 5.792, p < .01, CI [1.328, 2.732], as indicated within Table 2. 

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VAS Immediately After Local Sciatic: 
 
H0 : No statistically significant difference exists between the mean of the VAS 
Immediately After Local Sciatic for Needle Injections and the mean of VAS 
Immediately After Local Sciatic in the J-Tip Injections. 
 
Ha: A statistically significant difference exists between the mean of the VAS 
Immediately After Local Sciatic for Needle Injections and the mean of VAS 
Immediately After Local Sciatic in the J-Tip Injections. 
 
The VAS Immediately After Local Sciatic for J-Tip Injections exceeds the mean VAS 
Immediately After Local Sciatic for Needle Injections to a statistically significant degree, 
t(109) = 5.080, p < .01, [1.3587, 3.0974], as indicated within Table 2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Levene’s Test for 
Equality of 
Variances 
T-Test For Equality of Means 
 
95% 
Confidence 
Interval of the 
Difference 
F 
Significance 
t 
df 
Significance 
(2-tailed) 
Mean 
Difference 
Standard 
Error 
Difference 
Lower Upper 
VAS 
Immediately 
After Local 
Femoral 
Equal 
Variances 
Assumed 
4.491 
.036 
5.792 
109 
.000 
2.030 
.351 
1.336 
2.725 
Equal 
Variances 
Not 
Assumed 
 
 
5.741 
95.525 
.000 
2.030 
.354 
1.328 
2.732 
VAS 
Immediately 
After Local 
Equal 
Variances 
Assumed 
.515 
.474 
5.080 
109 
.000 
2.2281 
.4386 
1.3587 3.0974 

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Sciatic 
Equal 
Variances 
Not 
Assumed 
 
 
5.062 105.576 
.000 
2.2281 
.4401 
1.3554 3.1007 
Table 2: Independent Samples Test 
 
 
Ordinary Least Squares Regression: Visual Analogy Scores (VAS) After Local Femoral 
and Local Sciatic Nerve Blocks 
No statistical significance when comparing means Injection Type the following variables: 
1st Type of Sedation, 1st Total Quantity of sedation used (mg), 2nd Type of Sedation Used, 
Total Quantity 2nd Type of sedation used (mcg), 3rd Type of Sedation Used, Total 
Quantity 3rd Type of sedation used (mcg), Visual Analog Scale (VAS) prior to local 
femoral, VAS prior to femoral, VAS immediately after femoral, VAS prior to local 
sciatic, VAS prior to sciatic, VAS immediately after sciatic, VAS prior to PACU 
Discharge. 
 
VAS Immediately After Local Femoral: 
Ordinary Least Squares Regression is utilized to determine if the Visual Analog Scale 
(VAS) immediately after local femoral for Needle Injections is significantly different 
from J-Tip Injections. This regression is run to determine if the injection type can 
statistically predict VAS immediately after local femoral. There is an independence of 
residuals, as assessed by a Durbin-Watson statistic, of 1.688 (Table 4). The assumptions 
of linearity, independence of errors, homoscedasticity, unusual points, and normality of 
residuals were met. The model is statistically significant, F (6, 100) = 10.215, p ≤ .001, 
adj. R2 = .343. Injection type statistically significantly predicts VAS immediately after 
local femoral, as seen in Table 3, β = -2.020, t = -6.266, p ≤ .001. The beta explains that 
if a J-tip injection was given it would decrease the VAS immediately after local femoral 
by approximately 2. Regression coefficients and standard errors can be found in 
Appendix. 
Variable 
Adjusted R2 
Model 
Injection Type 
VAS Immediately 
After Local Femoral 
.343 
df 
F 
Sig. 
Beta 
T 
Sig. 
6 
10.215 
.000 
-
2.020 
-
6.266 
.000 
Table 3: Beta Explanation for VAS Immediately After Local Femoral 
 
 
Model 
R 
R2 
Adjusted R2 
Standard 
Error of the 
Estimate 
Durbin-
Watson 
1 
.616a 
.380 
.343 
1.656 
1.688 
a. Predictors: (Constant), Thigh Circumference (cm), Ethnicity, Injection Type, Age, 
Gender BMI 
b. Dependent Variable: VAS Immediately After Local Femoral 
Table 4: Model Summary 
 
 

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Model 
Sum of 
Squares 
dF 
Mean 
Square 
F 
Sig. 
1 
Regression 
168.140 
6 
28.023 
10.215 
.000b 
Residual 
274.327 
100 
2.743 
 
 
Total 
442.467 
106 
 
 
 
a. Dependent Variable: VAS Immediately After Local Femoral 
b. Predictors: (Constant), Thigh Circumference (cm), Ethnicity, Injection Type, Age, 
Gender BMI 
Table 5: ANOVAa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unstandardized 
Coefficients 
Standardized 
Coefficients 
 
95% Confidence 
Interval for B 
Model 
B 
Std. 
Error 
Beta 
t 
Sig. 
Lower 
Bound 
Upper 
Bound 
1 
(Constant) 
9.774 
2.119 
 
4.613 
.000 
5.570 
13.977 
Injection Type 
-2.020 
.322 
-.496 
-6.266 
.000 
-2.660 
-1.381 
Gender 
.504 
.340 
.124 
1.481 
.142 
-.171 
1.179 
Age 
-.250 
.105 
-.193 
-2.367 
.020 
-.459 
-.040 
Ethnicity 
-.021 
.117 
-.014 
-.177 
.860 
-.253 
.212 
BMI 
-.079 
.065 
-.186 
-1.225 
.223 
-.208 
.049 
Thigh 
Circumference 
(cm) 
-.021 
.038 
-.083 
-.545 
.587 
-.097 
.055 

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a. Dependent Variable: VAS Immediately After Local Femoral 
Table 7: Coefficientsa 
 
 
 
VAS immediately after local sciatic: 
Ordinary Least Squares Regression is utilized to determine if the Visual Analog Scale 
(VAS) immediately after local sciatic for Needle Injections is significantly different from 
J-Tip Injections. This regression is run to determine if the injection type can statistically 
predict VAS immediately after local sciatic. There is an independence of residuals, as 
assessed by a Durbin-Watson statistic, of 1.798 (Table 9). The assumptions of linearity, 
independence of errors, homoscedasticity, unusual points, and normality of residuals 
were met. The model is statistically significant, F (6, 100) = 6.178, p ≤ .001, adj. R2 = 
.227. Injection type statistically significantly predicts VAS immediately after local 
sciatic, as seen in Table 8 β = -2.248, t = -5.191, p ≤ .001. The beta explains that if a J-tip 
injection was given it would decrease the VAS) immediately after local sciatic by 
approximately 2. Regression coefficients and standard errors can be found in Appendix. 
 
Variable 
Adjusted R2 
Model 
Injection Type 
VAS Immediately 
After Local Sciatic 
.277 
df 
F 
Sig. 
Beta 
T 
Sig. 
6 
6.178 
.000 
-
2.248 
-
5.191 
.000 
Table 8: Beta Explanation for VAS Immediately After Local Sciatic 
 
 
 
Model 
R 
R2 
Adjusted R2 
Standard 
Error of the 
Estimate 
Durbin-
Watson 
1 
.520a 
.270 
.227 
2.2247 
1.798 
c. Predictors: (Constant), Thigh Circumference (cm), Ethnicity, Injection Type, Age, 
Gender BMI 
d. Dependent Variable: VAS Immediately After Local Sciatic 
Table 9: Model Summary 
 
 
Model 
Sum of 
Squares 
dF 
Mean 
Square 
F 
Sig. 
1 
Regression 
183.449 
6 
30.575 
6.178 
.000b 
Residual 
494.930 
100 
4.949 
 
 
Total 
678.379 
106 
 
 
 
c. Dependent Variable: VAS Immediately After Local Sciatic 

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d. Predictors: (Constant), Thigh Circumference (cm), Ethnicity, Injection Type, Age, 
Gender BMI 
Table 10: ANOVAa 
 
 
 
 
Unstandardized 
Coefficients 
Standardized 
Coefficients 
 
95% Confidence 
Interval for B 
Model 
B 
Std. 
Error 
Beta 
t 
Sig. 
Lower 
Bound 
Upper 
Bound 
1 
(Constant) 
9.130 
2.846 
 
3.208 
.002 
3.484 
14.777 
Injection Type 
-2.248 
.433 
-.446 
-5.191 
.000 
-3.107 
-1.389 
Gender 
.826 
.457 
.164 
1.807 
.074 
-.081 
1.179 
Age 
-.236 
.142 
-.147 
-1.665 
.099 
-.517 
-.040 
Ethnicity 
.005 
.157 
.003 
.033 
.973 
-.307 
.212 
BMI 
-.029 
.087 
-0.54 
-.329 
.743 
-.201 
.049 
Thigh 
Circumference 
(cm) 
-.028 
.051 
-.090 
-.543 
.588 
-.130 
.055 
b. Dependent Variable: VAS Immediately After Local Sciatic 
Table 11: Coefficientsa