Regional Anesthesia EMG Study

Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: BlockSynop surface electromyography device; Drug: Clonidine; Drug: Sevoflurane

Detailed Description

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. The hypothesis is that EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Group 1 (GA + penile block): age 5 years or below getting: circumcision or circumcision revision
• Group 2-5 (SA or GA + CA): age 5 years or below getting: penile or scrotal surgery, inguinal hernia repair, Achilles tendon lengthening, other applicable urological procedures
• Group 6 (GA only): age 5 years or below getting: operative dentistry, urological or ENT procedures

Exclusion Criteria:

• parent refusal
• systemic infection
• spine or CNS abnormalities
• medication allergy
• adhesive allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia with Penile Block; Penile block: prior to the start of surgery 0.5mg/kg of 0.25% bupivacaine w/o epinephrine will be administered GA : Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.	Device: 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.
Active Comparator: Spinal Anesthesia with Clonidine; Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.	Device: 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.; Drug: Clonidine; Clonidine is an alpha-2-agonist which is commonly used as an adjunct in spinal anesthesia and caudal anesthesia to improve both the quality and duration of blockade.
Active Comparator: Spinal Anesthesia without Clonidine; Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine	Device: 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.
Active Comparator: General Anesthesia with Caudal Anesthesia with Clonidine; Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.	Device: 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.; Drug: Clonidine; Clonidine is an alpha-2-agonist which is commonly used as an adjunct in spinal anesthesia and caudal anesthesia to improve both the quality and duration of blockade.; Drug: Sevoflurane; 5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
Active Comparator: General Anesthesia with Caudal Anesthesia without Clonidine; Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg	Device: 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.; Drug: Sevoflurane; 5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
Active Comparator: General Anesthesia only; GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.	Device: 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.; Drug: Sevoflurane; 5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or 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 duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .	Performance of non-invasive surface EMG following administration of regional and/or 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 spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or 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 dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.	Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.	Intraoperative time frame. Timeframe being day of surgery.

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Grant Heydinger, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethers; Azoles; Hydrocarbons; Imidazoles; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Imidazolines; Sevoflurane; Clonidine
• Other Study ID Numbers: STUDY00002844

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No