The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients

Overview

The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2021

Interventions

  • Device: Programmed intermittent epidural bolus
    • bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device
  • Device: Continuous epidural infusion
    • Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device

Arms, Groups and Cohorts

  • Experimental: PIEB (Programmed intermittent epidural bolus)
    • bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection)
  • Active Comparator: CEI (Continuous epidural infusion)
    • Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device

Clinical Trial Outcome Measures

Primary Measures

  • Difference in total amount of ropivacaine injected through epidural analgesia
    • Time Frame: 6 hours after surgery
    • The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively
  • Difference in total amount of ropivacaine injected through epidural analgesia
    • Time Frame: 12 hours after surgery
    • The difference in the amount of ropivacaine injected into epidural space for 12 hours postoperatively
  • Difference in total amount of ropivacaine injected through epidural analgesia
    • Time Frame: 24 hours after surgery
    • The difference in the amount of ropivacaine injected into epidural space for 24 hours postoperatively
  • Difference in total amount of ropivacaine injected through epidural analgesia
    • Time Frame: 36 hours after surgery
    • The difference in the amount of ropivacaine injected into epidural space for 36 hours postoperatively
  • Difference in total amount of ropivacaine injected through epidural analgesia
    • Time Frame: 48 hours after surgery
    • The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively

Secondary Measures

  • The time for the first patient controlled rescue epidural bolus after surgery
    • Time Frame: 48 hours after surgery
  • Number of patient-controlled rescue epidural bolus for 48 hours postoperatively
    • Time Frame: 48 hours after surgery
  • Pain scores for 6 hours after surgery (VAS)
    • Time Frame: 6 hours after surgery
    • VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
  • Pain scores for 12 hours after surgery (VAS)
    • Time Frame: 12 hours after surgery
    • VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
  • Pain scores for 24 hours after surgery (VAS)
    • Time Frame: 24 hours after surgery
    • VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
  • Pain scores for 48 hours after surgery (VAS)
    • Time Frame: 48 hours after surgery
    • VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)
  • Pain scores for 6 hours after surgery (r-FLACC)
    • Time Frame: 6 hours after surgery
    • r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
  • Pain scores for 12 hours after surgery (r-FLACC)
    • Time Frame: 12 hours after surgery
    • r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
  • Pain scores for 24 hours after surgery (r-FLACC)
    • Time Frame: 24 hours after surgery
    • r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
  • Pain scores for 48 hours after surgery (r-FLACC)
    • Time Frame: 48 hours after surgery
    • r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.
  • Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
    • Time Frame: 48 hours after surgery
    • -% of patients with given intravenous additional narcotic analgesics number of administrating intravenous additional narcotic analgesics per patient
  • Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
    • Time Frame: 48 hours after surgery
    • -% of patients with given intravenous additional narcotic analgesics total additional dose of intravenous narcotic analgesics per patient
  • Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
    • Time Frame: 48 hours after surgery
    • -% of patients with given intravenous additional narcotic analgesics measurement tool: Electronic Medical Record(including Drug administration history)
  • A dull feeling the patient feels
    • Time Frame: 6 hours after surgery
    • A dull feeling the patient feels : yes or no
  • A dull feeling the patient feels
    • Time Frame: 12 hours after surgery
    • A dull feeling the patient feels : yes or no
  • A dull feeling the patient feels
    • Time Frame: 24 hours after surgery
    • A dull feeling the patient feels : yes or no
  • A dull feeling the patient feels
    • Time Frame: 48 hours after surgery
    • A dull feeling the patient feels : yes or no

Participating in This Clinical Trial

Inclusion Criteria

  • 1. Pediatric patients with between 4 and 13 years
  • 2. Patients scheduled for correctional osteotomy of the lower extremity
  • 3. Pediatric patients whose weight of 40kg of less

Exclusion Criteria

  • 1. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
  • 2. Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure
  • 3. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yong Seon Choi, MD., PhD., 82-2-2228-2412, YSCHOI@yuhs.ac

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