Peripheral Regional Blockade and EMG

NCT ID: NCT06982027

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BlockSynop surface electromyography device

Intervention Type: 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

Intervention Type: PROCEDURE

An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients ≤ 21 years of age
• Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used

Exclusion Criteria

• Patients > 21 years of age
• Parent / patient refusal
• Premature infants; neuromuscular disease; systemic infection; hemodynamic instability; coagulation disorder; degenerative CNS abnormality that precludes regional anesthesia; and local anesthetic allergy; pregnant women.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Grant Heydinger

Principal Investigator - MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grant Heydinger, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

STUDY00004642

Identifier Type: -

Identifier Source: org_study_id