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

Not Applicable
Completed
Conditions
Knee Injury
Interventions
Device: Syringe and 25 gauge needle
Device: J-Tip
Registration Number
NCT02649322
Lead Sponsor
Orlando Health, Inc.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
115
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group BSyringe and 25 gauge needleParticipants 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 AJ-TipParticipants 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.
Primary Outcome Measures
NameTimeMethod
Pain Assessment After Knee Arthroscopy Via the Visual Analog ScaleDuring Follow-up Assessment at an Average of 1 Week Post Op

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. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.

Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block

Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.

Secondary Outcome Measures
NameTimeMethod
Satisfaction Via a 0 to 10 Rating Scale at Follow upAt 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. Patient will report on a scale of 0 to 10 what their perceived satisfaction is. 0 is no satisfaction with 10 most satisfaction.

Trial Locations

Locations (1)

Orlando Health

🇺🇸

Orlando, Florida, United States

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