Peripheral Regional Blockade and EMG

Not Applicable

Not yet recruiting

• Conditions: Surgery

• Registration Number: NCT06982027
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States