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Status unknownNCT02144766Updated Aug 26, 2014

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

A Phase 4 interventional study of ropivacaine and saline in Cardiac Dysfunction and Myocardial Injury, sponsored by Si-Qin Chen. Status unknown at 1 site in China. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2014-08-26.

Sponsored by Si-Qin Chen · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
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Study summary

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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Conditions studied

  • Cardiac Dysfunction
  • Myocardial Injury

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

This is the only study on the registry with Si-Qin Chen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ropivacaine

    caudal block with 1 ml/kg of ropivacaine 0.2%

    Drug: ropivacaine

  • Placebo comparator
    saline

    caudal block with 1 ml/kg of saline

    Drug: saline

Interventions

  • Drugropivacaine

    caudal block with 1 ml/kg of ropivacaine 0.2%

  • Drugsaline

    caudal block with 1 ml/kg of saline

06

What researchers measure

Primary outcomes

  1. change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit

    Time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  2. change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery

    Time frame: baseline(before induction of anesthesia), 3h after surgery

  3. change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery

    Time frame: baseline(before induction of anesthesia), 24h after surgery

  4. change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery

    Time frame: baseline(before induction of anesthesia), 48h after surgery

  5. change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery

    Time frame: baseline(before induction of anesthesia), 72h after surgery

  6. change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit

    Time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  7. change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery

    Time frame: baseline(before induction of anesthesia), 3h after surgery

  8. change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery

    Time frame: baseline(before induction of anesthesia), 24h after surgery

  9. change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery

    Time frame: baseline(before induction of anesthesia), 48h after surgery

  10. change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery

    Time frame: baseline(before induction of anesthesia), 72h after surgery

  11. change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit

    Time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  12. change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery

    Time frame: baseline(before induction of anesthesia), 3h after surgery

  13. change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery

    Time frame: baseline(before induction of anesthesia), 24h after surgery

  14. change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery

    Time frame: baseline(before induction of anesthesia), 48h after surgery

  15. change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery

    Time frame: baseline(before induction of anesthesia), 72h after surgery

  16. change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit

    Time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  17. change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery

    Time frame: baseline(before induction of anesthesia), 3h after surgery

  18. change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery

    Time frame: baseline(before induction of anesthesia), 24h after surgery

  19. change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery

    Time frame: baseline(before induction of anesthesia), 48h after surgery

  20. change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery

    Time frame: baseline(before induction of anesthesia), 72h after surgery

  21. change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit

    Time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  22. change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery

    Time frame: baseline(before induction of anesthesia), 3h after surgery

  23. change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery

    Time frame: baseline(before induction of anesthesia), 24h after surgery

  24. change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery

    Time frame: baseline(before induction of anesthesia), 48h after surgery

  25. change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery

    Time frame: baseline(before induction of anesthesia), 72h after surgery

Secondary outcomes

  1. change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit

    Time frame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  2. change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery

    Time frame: baseline(just before the start of surgery), 3h after surgery

  3. change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit

    Time frame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  4. change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery

    Time frame: baseline(just before the start of surgery), 3h after surgery

  5. change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit

    Time frame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  6. change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery

    Time frame: baseline(just before the start of surgery), 3h after surgery

07

Study locations

1 of 1 sites recruiting
  • Xinhua Hospital
    Shanghai, 200092, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02144766
Lead sponsor
Si-Qin Chen
Responsible party
Si-Qin Chen (attending doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
May 22, 2014
Start date
Apr 2014
Primary completion
Sep 2014 (estimated)
Completion
Oct 2014 (estimated)
Last update
Aug 26, 2014

Study contacts

SiQin Chen, MD
Contact
chensiqin1983@hotmail.com
+8613918085974

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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