Surgery
Conditions
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.
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
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.
PROCEDUREPeripheral nerve block
An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude. | 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. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. | Intraoperative time frame. Timeframe being day of surgery. | Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. |
Countries
United States
Outcome results
None listed