High Volume Caudal Study

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Male Circumcision

Treatments: Drug: High Volume-Low Concentration with clonidine; Drug: High Volume-Low Concentration without Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04263064

Pro00091670

Details and patient eligibility

About

The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.

Enrollment: 129 patients

Sex: Male

Ages: Under 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 3 years old or less
• 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

• Known allergy to clonidine, epinephrine, or amide local anesthetics
• Inability or unwillingness of parent or legal guardian to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 2 patient groups

High Volume-Low Concentration without Clonidine

Active Comparator group

Description:

The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine).

Treatment:

Drug: High Volume-Low Concentration without Clonidine

High Volume-Low Concentration with clonidine

Experimental group

Description:

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).

Treatment:

Drug: High Volume-Low Concentration with clonidine