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

Orlando Health, Inc.

Status: Completed

Conditions: Knee Injury

Treatments: Device: Syringe and 25 gauge needle; Device: J-Tip

Study type: Interventional

Funder types: Other

Identifiers

NCT02649322

14.099.08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Group A

Experimental group

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.

Treatment:

Device: J-Tip

Group B

Active Comparator group

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.

Treatment:

Device: Syringe and 25 gauge needle