Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

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The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.

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Detailed Description

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Conditions

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Cardiac Dysfunction Myocardial Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine

caudal block with 1 ml/kg of ropivacaine 0.2%

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

caudal block with 1 ml/kg of ropivacaine 0.2%

saline

caudal block with 1 ml/kg of saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

caudal block with 1 ml/kg of saline

Interventions

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ropivacaine

caudal block with 1 ml/kg of ropivacaine 0.2%

Intervention Type DRUG

saline

caudal block with 1 ml/kg of saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.

Exclusion Criteria

* Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No