NCT02649322

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-09-03
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2016-01-07
• Last updated: 2020-05-05
• Results posted: 2020-04-28

Locations

1 site across 1 country: United States