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Enrolling by Invitation

NCT Number: NCT06982027

Peripheral Regional Blockade and EMG

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.

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Key information

Conditions

Surgery

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

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

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

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

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

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

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

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

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

Secondary outcomes

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

    Time frame: Intraoperative time frame. Timeframe being day of surgery.

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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Acronym: Electromyogram

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 21, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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