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Enrolling by invitation NCT06982027

Peripheral Regional Blockade and EMG

No phase Interventional Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BlockSynop surface electromyography device, Peripheral nerve block.
Who it may be relevant to
Registry conditions: Surgery. Basic parameters: 0 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT06982027 · STUDY00004642

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗