Peripheral Regional Blockade and EMG

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT06982027
Status
Enrolling By Invitation

Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • BlockSynop surface electromyography device — DEVICE
    The EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device.
  • Peripheral nerve block — PROCEDURE
    An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.

Study Details

The investigators are studying a type of technology that is already used called surface electromyography (EMG). This measures and records electrical activity using sensor stickers in a non-invasive way. The purpose of this study is to use a prototype/test surface EMG machine to measure how well regional anesthesia (nerve block) is working. This device is non-invasive and being used for research use as an unapproved medical device. The information may teach us how to give nerve blocks more safely and effectively. Study participation: Subjects having surgery will have the surface EMG sensor stickers placed on their arms or legs before surgery. These will stay on during surgery and for part of recovery. Study visits: The study will consist of 1 visit that starts in the pre-operative area, through the surgery, and for part of recovery time after surgery.

Key Dates

Start date
Sep 3, 2025
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: General Anesthesia with peripheral regional block
    All patients will have general anesthesia and a peripheral regional block (upper or lower extremity block). EMG electrodes will be placed on both the extremity to be blocked in two dermatomes within the sensory distribution of the nerve and then in the same two sensory dermatomes on the contralateral extremity that is not being blocked.

Primary Outcome Measure

Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude. [ Time Frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

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By research site
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