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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Orlando Health, Inc.

Current Primary Outcome:

  • Pain assessment before knee arthroscopy via the Visual Analog Scale. [ Time Frame: From baseline to time of the administration of the nerve block, an average of 20 minutes. ]
    Pain will be assess via the Visual Analog Scale by the patient before administration of the nerve block.
  • Pain assessment after knee arthroscopy via the Visual Analog Scale [ Time Frame: From after the knee block through the first post op visit, an average of one week. ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Satisfaction via a 0 to 10 rating scale [ Time Frame: At the follow up appointment, an average of one week after the procedure. ]

Patients will be asked to describe how satisfied they were with the knee arthroscopy via a 0 to 10 rating scale.


Original Secondary Outcome: Same as current

Information By: Orlando Health, Inc.

Dates:
Date Received: December 13, 2015
Date Started: December 2015
Date Completion: June 2018
Last Updated: September 28, 2016
Last Verified: September 2016