Peripheral Regional Blockade and EMG
NCT06982027 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-10-30
Summary
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.
Conditions
- Surgery
Interventions
- DEVICE
-
BlockSynop surface electromyography 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.
- PROCEDURE
-
Peripheral nerve block
An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.
Sponsors & Collaborators
-
Nationwide Children's Hospital
lead OTHER
Principal Investigators
-
Grant Heydinger, MD · Nationwide Children's Hospital
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-03
- Primary Completion
- 2027-01-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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