Clinical trial NCT02649322: Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
Official title: Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injury
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 115
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
timeFrame: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
measure: Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
timeFrame: During Follow-up Assessment at an Average of 1 Week Post Op
Secondary outcomes:
measure: Satisfaction Via a 0 to 10 Rating Scale at Follow up
timeFrame: At the follow up appointment, an average of one week after the procedure.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Daryl C Osbahr, MD
role: PRINCIPAL_INVESTIGATOR
References: