Surface Electromyography for Surgery

(Electromyogram Trial)

Overseen By Julie Rice-Weimer

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Age > 21, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a device called surface electromyography (EMG) can improve the safety and effectiveness of nerve blocks during surgery. Surface EMG uses sensor stickers to measure electrical activity in muscles without needles. The goal is to determine if this technology can ensure proper functioning of nerve blocks. Participants must be 21 years or younger and scheduled for surgery with both general anesthesia and a nerve block. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical safety and effectiveness.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for use in surgery?

Previous studies have shown that surface electromyography (EMG) is safe and non-invasive. It doesn't require surgery and uses sensor stickers on the skin to measure electrical activity. Research indicates that patients generally tolerate this method well, with no reports of serious side effects. The EMG device in this study is not yet approved for medical use and is being tested in a research setting. However, its safety record remains promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Surface Electromyography for Surgery trial because it explores a unique method of monitoring nerve blocks during surgery. Unlike traditional nerve monitoring techniques that might rely on subjective assessments or invasive methods, the BlockSynop surface electromyography device offers a non-invasive way to measure muscle activity and nerve function. By placing EMG electrodes on both the blocked and unblocked extremities, this approach aims to provide more precise and reliable feedback on the effectiveness of nerve blocks, potentially enhancing patient outcomes and surgical precision.

What evidence suggests that the surface electromyography device is effective for measuring nerve block efficacy?

Research has shown that surface electromyography (EMG) can effectively verify the effectiveness of a nerve block during surgery. In this trial, participants will receive general anesthesia with a peripheral regional block, and the BlockSynop surface electromyography device will assess the nerve block's effectiveness. Studies have found that this method is non-invasive, requiring no surgery or needles. The technology uses sensor stickers to track electrical activity in the body. Early findings suggest that EMG holds promise for accurately assessing nerve block effectiveness, contributing to safer and more effective surgeries. ^{1 3 4 6 7}

Who Is on the Research Team?

Grant Heydinger, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery who are interested in helping test a new surface electromyography (EMG) device. The device uses sensor stickers to measure muscle activity and assess the effectiveness of nerve blocks given for anesthesia.

Inclusion Criteria

I am scheduled for surgery with general anesthesia and a regional block.

I am 21 years old or younger.

Exclusion Criteria

My baby was born early.

I have a systemic infection.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Preoperative

Surface EMG sensor stickers are placed on the extremities before surgery

1 day

1 visit (in-person)

Intraoperative

EMG monitoring is used to measure the onset and density of peripheral nerve blockade during surgery

1 day

1 visit (in-person)

Postoperative

EMG monitoring continues to assess the resolution of motor blockade in the PACU

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

What Are the Treatments Tested in This Trial?

Interventions

• BlockSynop surface electromyography device

Trial Overview

The study is testing a prototype surface EMG machine, which records electrical activity in muscles non-invasively to evaluate regional anesthesia during surgery. Participants will have one visit involving pre-operative setup, monitoring during surgery, and part of post-surgery recovery.

How Is the Trial Designed?

Group I: General Anesthesia with peripheral regional block Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06287151

NCT06287151 | Regional Anesthesia EMG Study

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06982027?lastUpdPost=2020-01-10_

NCT06982027 | Peripheral Regional Blockade and EMG

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- ...

3.

withpower.com

withpower.com/trial/surface-electromyography-for-surgery-b6742

Surface Electromyography for Surgery · Info for Participants

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- ...

4.

ctv.veeva.com

ctv.veeva.com/study/peripheral-regional-blockade-and-emg

Peripheral Regional Blockade and EMG - ClinicalTrials.Veeva

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 ...

5.

blocksynop.com

blocksynop.com/wp-content/uploads/2020/10/6-Ulnar_Study_SPPM_Poster_2020.pdf

Discrete Measure of Block Onset and Density in Awake ...

This study demonstrates not only the feasibility and promise of using passive surface EMG as an objective measure of the effectiveness of regional blockade, but ...

6.

blocksynop.com

blocksynop.com/for-clinicians/

For Clinicians

The goal of this observational study was to objectively define the rate of onset, maximum effect, and duration of infant SA versus CEA using continuous sEMG.

7.

blocksynop.com

blocksynop.com/news/

News

Surface electromyography (sEMG) is a safe, inexpensive, and non-invasive method to study the behavior of neural blockade. The goal of this observational study ...