search
Back to results

Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy

Primary Purpose

Knee Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
J-Tip
Syringe and 25 gauge needle
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Injury

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.

  • Able to independently complete the Visual Analog pain scales.
  • Subjects who are neurologically intact at area of injection.
  • English speaking.

Exclusion Criteria:

  • 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 Non-steroidal anti-inflammatory medications.
  • 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.

Sites / Locations

  • Orlando Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.

Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.

Outcomes

Primary Outcome Measures

Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.

Secondary Outcome Measures

Satisfaction Via a 0 to 10 Rating Scale at Follow up
Patients will be asked to describe how satisfied they were with the knee arthroscopy via a 0 to 10 rating scale. Patient will report on a scale of 0 to 10 what their perceived satisfaction is. 0 is no satisfaction with 10 most satisfaction.

Full Information

First Posted
December 13, 2015
Last Updated
April 27, 2020
Sponsor
Orlando Health, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02649322
Brief Title
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
Official Title
Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2015 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The J-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. The use of the J-tip device 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. This study seeks to evaluate the difference in pain from local anesthetic infiltration with J-tip needleless injection device compared to needle injection by use of Visual Analog Scales. To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post operatively by use of Visual Analog Scales. To assess patient and parent satisfaction with J-tip device use by satisfaction questionnaire. To assess changes in post operative pain medication amounts with J-tip device use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.
Intervention Type
Device
Intervention Name(s)
J-Tip
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Syringe and 25 gauge needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
Description
Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Time Frame
During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
Title
Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
Description
Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Time Frame
During Follow-up Assessment at an Average of 1 Week Post Op
Secondary Outcome Measure Information:
Title
Satisfaction Via a 0 to 10 Rating Scale at Follow up
Description
Patients will be asked to describe how satisfied they were with the knee arthroscopy via a 0 to 10 rating scale. Patient will report on a scale of 0 to 10 what their perceived satisfaction is. 0 is no satisfaction with 10 most satisfaction.
Time Frame
At the follow up appointment, an average of one week after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery. Able to independently complete the Visual Analog pain scales. Subjects who are neurologically intact at area of injection. English speaking. Exclusion Criteria: 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 Non-steroidal anti-inflammatory medications. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl C Osbahr, MD
Organizational Affiliation
Orlando Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy

We'll reach out to this number within 24 hrs