Peripheral Regional Blockade and EMG

NCT06982027 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00004642
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

• Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.

  Performance of non-invasive surface EMG following administration of peripheral nerve blockade + general anesthesia. This will be assessed by EMG signal amplitude.

  Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day.

• Determine resolution of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.

  Performance of non-invasive surface EMG following administration of peripheral nerve blockade and general anesthesia. This will be assessed by EMG signal amplitude.

  Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

• Determine density of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.

  Performance of non-invasive surface EMG following administration of peripheral nerve block and general anesthesia. This will be assessed by EMG signal amplitude.

  Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

Secondary Outcomes (1)

• Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.

  Intraoperative time frame. Timeframe being day of surgery.

Study Arms (1)

General Anesthesia with peripheral regional block

EXPERIMENTAL

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.

Device: BlockSynop surface electromyography device; Procedure: Peripheral nerve block

Interventions

BlockSynop surface electromyography device 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.

General Anesthesia with peripheral regional block

Peripheral nerve block PROCEDURE

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

General Anesthesia with peripheral regional block

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Grant Heydinger, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - MD

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)