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

Not Applicable

Completed

• Conditions: Preemptive Epidural Analgesia; Pediatric Surgical Patients
• Interventions: Procedure: 0.2 ml/kg of 0.2% ropivacaine; Procedure: 0.2mg/kg of Normal Saline

• Registration Number: NCT02813018
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Study Start: 2016-07-07
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
FLACC scale score (Face, Legs, Activity, Cry, Consolability)	0-6 hours after the operation

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of