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

NCT02649322 | Completed Results

• 1 other identifier: 14.099.08
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injury

Outcome Measures

Primary Outcomes (2)

• Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.

  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.

  During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block

• Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale

  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.

  During Follow-up Assessment at an Average of 1 Week Post Op

Secondary Outcomes (1)

• Satisfaction Via a 0 to 10 Rating Scale at Follow up

  At the follow up appointment, an average of one week after the procedure.

Study Arms (2)

Group A

EXPERIMENTAL

Participants 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.

Device: J-Tip

Group B

ACTIVE COMPARATOR

Participants 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.

Device: Syringe and 25 gauge needle

Interventions

J-Tip DEVICE

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.

Group A

Syringe and 25 gauge needle DEVICE

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.

Group B

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Syringes

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Daryl C. Osbahr, MD
• Organization: Orlando Health

Daryl.Osbahr@orlandohealth.com

321.843.4800

Study Officials

• Daryl C Osbahr, MD

  Orlando Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sports Medicine Orthopaedic physician

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: January 7, 2016
• Study Start: September 3, 2015
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: May 5, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)