SurgeryElectromyogramNCT06982027
Peripheral Regional Blockade and EMG
A study testing BlockSynop surface electromyography device and Peripheral nerve block in people with Surgery, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Surgery
- What is being tested?
- BlockSynop surface electromyography device and Peripheral nerve block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients ≤ 21 years of age
- Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity
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.
Read the detailed description
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.
- Conditions
- Surgery
- Being tested
- BlockSynop surface electromyography device, Peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlockSynop surface electromyography deviceDevice
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 blockProcedure or surgery
An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BlockSynop surface electromyography device; Procedure: Peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.
Measured: Intraoperative time frame. Timeframe being day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start3 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant Heydinger, Nationwide Children's Hospital
- Investigators
- Grant Heydinger, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982027
- Sponsor's protocol ID
- STUDY00004642
- Acronym
- Electromyogram
- Status last verified
- Oct 2025
- First submitted
- 13 May 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity
- ClinicalTrials.gov ID
- NCT06982027
- Acronym / sponsor ID
- Electromyogram / STUDY00004642
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia with peripheral regional block | Experimental | Device: BlockSynop surface electromyography device, Procedure: Peripheral nerve blockAll 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 may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients ≤ 21 years of age
- Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlockSynop surface electromyography deviceThe 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. | Device | General Anesthesia with peripheral regional block |
| Peripheral nerve blockAn injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery. | Procedure or surgery | General Anesthesia with peripheral regional block |
Primary outcome
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.
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.
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.
1 secondary outcome
Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.
Time frame: Intraoperative time frame. Timeframe being day of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grant Heydinger, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlockSynop surface electromyography device and Peripheral nerve block in people with Surgery, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.