Clinical trial NCT06982027: Peripheral Regional Blockade and EMG
Official title: Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We 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.

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.

Primary outcomes:
measure: Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
timeFrame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day.
measure: Determine resolution of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
timeFrame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
measure: Determine density of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
timeFrame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Secondary outcomes:
measure: Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.
timeFrame: Intraoperative time frame. Timeframe being day of surgery.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Grant Heydinger, MD
role: PRINCIPAL_INVESTIGATOR
References: