Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
129 participants
INTERVENTIONAL
2020-03-06
2022-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Volume-Low Concentration without Clonidine
The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine).
High Volume-Low Concentration without Clonidine
The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block
High Volume-Low Concentration with clonidine
The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
High Volume-Low Concentration with clonidine
The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
Interventions
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High Volume-Low Concentration without Clonidine
The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block
High Volume-Low Concentration with clonidine
The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
Eligibility Criteria
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Inclusion Criteria
* Weight \<= 13.3kg
* American Society of Anesthesiology Physical Status (ASA) 1 or 2
* Undergoing circumcision surgery
* Patients whose plan of care includes caudal block
Exclusion Criteria
* Inability or unwillingness of parent or legal guardian to give informed consent
0 Years
3 Years
MALE
Yes
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Christopher Heine, MD
Assistant Professor
Principal Investigators
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Christopher Heine, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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Pro00091670
Identifier Type: -
Identifier Source: org_study_id
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