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

Study Overview
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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.

Official Title
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Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block

Conditions
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Cardiac Dysfunction, Myocardial Injury

Intervention / Treatment
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* Drug: ropivacaine
* Drug: saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>caudal block with 1 ml/kg of ropivacaine 0.2% | Drug: ropivacaine<br>* caudal block with 1 ml/kg of ropivacaine 0.2%<br>|
| Placebo Comparator: saline<br>caudal block with 1 ml/kg of saline | Drug: saline<br>* caudal block with 1 ml/kg of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit |  | baseline(before induction of anesthesia), arrival in the postanesthesia care unit | 
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery |  | baseline(before induction of anesthesia), 3h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery |  | baseline(before induction of anesthesia), 24h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery |  | baseline(before induction of anesthesia), 48h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery |  | baseline(before induction of anesthesia), 72h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit |  | baseline(before induction of anesthesia), arrival in the postanesthesia care unit | 
| change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery |  | baseline(before induction of anesthesia), 3h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery |  | baseline(before induction of anesthesia), 24h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery |  | baseline(before induction of anesthesia), 48h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery |  | baseline(before induction of anesthesia), 72h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit |  | baseline(before induction of anesthesia), arrival in the postanesthesia care unit | 
| change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery |  | baseline(before induction of anesthesia), 3h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery |  | baseline(before induction of anesthesia), 24h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery |  | baseline(before induction of anesthesia), 48h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery |  | baseline(before induction of anesthesia), 72h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit |  | baseline(before induction of anesthesia), arrival in the postanesthesia care unit | 
| change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery |  | baseline(before induction of anesthesia), 3h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery |  | baseline(before induction of anesthesia), 24h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery |  | baseline(before induction of anesthesia), 48h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery |  | baseline(before induction of anesthesia), 72h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit |  | baseline(before induction of anesthesia), arrival in the postanesthesia care unit | 
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery |  | baseline(before induction of anesthesia), 3h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery |  | baseline(before induction of anesthesia), 24h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery |  | baseline(before induction of anesthesia), 48h after surgery | 
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery |  | baseline(before induction of anesthesia), 72h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit |  | baseline(just before the start of surgery), at arrival in the postanesthesia care unit | 
| change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery |  | baseline(just before the start of surgery), 3h after surgery | 
| change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit |  | baseline(just before the start of surgery), at arrival in the postanesthesia care unit | 
| change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery |  | baseline(just before the start of surgery), 3h after surgery | 
| change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit |  | baseline(just before the start of surgery), at arrival in the postanesthesia care unit | 
| change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery |  | baseline(just before the start of surgery), 3h after surgery |