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The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

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Yonsei University

Status

Completed

Conditions

Pediatric Surgical Patients
Preemptive Epidural Analgesia

Treatments

Procedure: 0.2mg/kg of Normal Saline
Procedure: 0.2 ml/kg of 0.2% ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02813018
4-2016-0322

Details and patient eligibility

About

Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

Enrollment

50 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
  • ASA class I and II

Exclusion criteria

  • Coagulopathy
  • Neurological disease
  • Allergy to local anesthetics or contraindication to use of ropivacaine
  • Infection at the site of epidural catheter insertion

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

preemptive group
Experimental group
Description:
Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.
Treatment:
Procedure: 0.2 ml/kg of 0.2% ropivacaine
saline group
Placebo Comparator group
Description:
Group who will be received saline bolus and continous infusion 5 minutes before skin incision
Treatment:
Procedure: 0.2mg/kg of Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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