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General Anesthesia with Penile Block for Surgery

N/A
Recruiting
Led By Grant Heydinger, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative time frame. timeframe being day of surgery.
Awards & highlights

Study Summary

This trial will use a non-invasive monitoring technique called EMG to study how spinal and caudal anesthesia works in children during surgery. They will also look at how adding clonidine affects the

Who is the study for?
This trial is for pediatric patients needing surgery where spinal or caudal blockade anesthesia will be used. It's designed to test a non-invasive EMG monitoring device during the operation. Patients with conditions that might interfere with EMG readings or those who can't receive the study drugs may not qualify.Check my eligibility
What is being tested?
The study tests how well an EMG device can track anesthesia effects in real-time during surgery. It also looks at whether adding clonidine to the anesthesia affects these readings, and it examines sevoflurane's impact on muscle tone through EMG data.See study design
What are the potential side effects?
Possible side effects include typical reactions to clonidine like low blood pressure, dry mouth, and sedation; as well as common responses to sevoflurane such as nausea and shivering post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 5 years old or younger and need a circumcision or its revision.
Select...
My child is 5 or younger and needs specific surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative placement through resolution of motor blockade in the pacu. timeframe being day of surgery - up to one day.
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative placement through resolution of motor blockade in the pacu. timeframe being day of surgery - up to one day. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .
+1 more
Secondary outcome measures
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.
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.
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.
+2 more

Trial Design

6Treatment groups
Active Control
Group I: General Anesthesia with Penile BlockActive Control1 Intervention
Penile block: prior to the start of surgery 0.5mg/kg of 0.25% bupivacaine w/o epinephrine will be administered GA : Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
Group II: General Anesthesia onlyActive Control2 Interventions
GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
Group III: General Anesthesia with Caudal Anesthesia with ClonidineActive Control3 Interventions
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
Group IV: Spinal Anesthesia without ClonidineActive Control1 Intervention
Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine
Group V: General Anesthesia with Caudal Anesthesia without ClonidineActive Control2 Interventions
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg
Group VI: Spinal Anesthesia with ClonidineActive Control2 Interventions
Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,382 Total Patients Enrolled
5 Trials studying Surgery
5,001,382 Patients Enrolled for Surgery
Grant Heydinger, MDPrincipal InvestigatorNationwide Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"As per the details available on clinicaltrials.gov, this specific research investigation is actively seeking eligible participants. The trial was initially listed on August 9th, 2023 and has been most recently revised on February 27th, 2024."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the details on clinicaltrials.gov highlight that this research study is currently seeking eligible participants. The trial was initially uploaded on August 9th, 2023 and last revised on February 27th, 2024. Enrollment aims to reach a total of 124 individuals at one designated site."

Answered by AI

May I inquire about the criteria for potential participation in this medical study?

"To be eligible for this research study, participants must have undergone a surgical procedure and fall within the age bracket of 0 to 5 years. The trial has availability for up to 124 individuals."

Answered by AI

Is there an inclusion of individuals aged 55 and above in this research trial?

"To be eligible for this study, subjects must be between the ages of zero and five years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Regional Anesthesia EMG Study
Grant Heydinger 2023. "Regional Anesthesia EMG Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06287151.
~58 spots leftby Dec 2024
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