Clinical trial NCT06287151: Regional Anesthesia EMG Study
Official title: Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 124
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Choice of group will be made by attending anesthesiologist based on clinical judgement.
Primary purpose: OTHER

Brief summary: This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.

Detailed description: This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. The hypothesis is that EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

Eligibility criteria: Inclusion Criteria:

* Group 1 (GA + penile block): age 5 years or below getting: circumcision or circumcision revision
* Group 2-5 (SA or GA + CA): age 5 years or below getting: penile or scrotal surgery, inguinal hernia repair, Achilles tendon lengthening, other applicable urological procedures
* Group 6 (GA only): age 5 years or below getting: operative dentistry, urological or ENT procedures

Exclusion Criteria:

* parent refusal
* systemic infection
* spine or CNS abnormalities
* medication allergy
* adhesive allergy

Primary outcomes:
measure: Determine onset of spinal anesthesia and caudal + 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 duration of spinal anesthesia and caudal + 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 spinal anesthesia and caudal + 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 dermatomal level of spinal anesthesia and caudal + 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: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude.
timeFrame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude.
timeFrame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude.
timeFrame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude.
timeFrame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
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: