CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled
Drug / intervention
J-Tip +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02649322
NCT02649322N/ACompleted

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

Orlando Health, Inc.·interventional·Posted Jan 7, 2016·Updated May 5, 2020

In Brief

A clinical study evaluating J-Tip and Syringe and 25 gauge needle for Knee Injury. Completed, enrolled 115 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 7, 2016
Enrollment StartSep 3, 2015
Primary CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.5 years ago

Interventions

J-Tipdevice

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.

Syringe and 25 gauge needledevice

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.