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

NCT ID: NCT02649322

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-03
• Study Completion Date: 2019-08-28

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.

Conditions

Knee Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

J-Tip

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Syringe and 25 gauge needle

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orlando Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Daryl Osbahr

Sports Medicine Orthopaedic physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daryl C Osbahr, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Health

Locations

Orlando Health

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14.099.08

Identifier Type: -

Identifier Source: org_study_id