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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

We 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.

Research Team

Grant Heydinger, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: General Anesthesia with peripheral regional block Experimental Treatment 1 Intervention

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+