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

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

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Injury; Cardiac Dysfunction
• Intervention / Treatment: Drug: ropivacaine; Drug: saline

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SiQin Chen, MD; Phone Number: +8613918085974; Email: chensiqin1983@hotmail.com

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine; caudal block with 1 ml/kg of ropivacaine 0.2%	Drug: ropivacaine; caudal block with 1 ml/kg of ropivacaine 0.2%
Placebo Comparator: saline; caudal block with 1 ml/kg of saline	Drug: saline; caudal block with 1 ml/kg of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Si-Qin Chen

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: May 11, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 24, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 060717