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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Injury
• Intervention / Treatment: Device: J-Tip; Device: Syringe and 25 gauge needle

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Device: J-Tip; 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.
Active Comparator: Group B; 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.	Device: Syringe and 25 gauge needle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
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.	During Follow-up Assessment at an Average of 1 Week Post Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the follow up appointment, an average of one week after the procedure.

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Investigators: Principal Investigator: Daryl C Osbahr, MD, Orlando Health

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2015
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: 14.099.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No