NCT06982027

Peripheral Regional Blockade and EMG

Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize peripheral nerve blockade (upper or lower extremity) in pediatric, adolescent, and young adult patients undergoing surgery. We also aim to quantify the impact of sevoflurane (general anesthesia) on basal muscle tone based on EMG changes. Hypothesis: EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

Conditions

• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2025-05-21
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study