High Volume Caudal Study

NCT ID: NCT04263064

Last Updated: 2023-03-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2022-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Male Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcome assessor and patient blinded to the medications in the block that the patient receives.

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).

Group Type ACTIVE_COMPARATOR

High Volume-Low Concentration without Clonidine

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

High Volume-Low Concentration with clonidine

Intervention Type DRUG

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

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

3 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Christopher Heine, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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Pro00091670

Identifier Type: -

Identifier Source: org_study_id

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