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

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 Overview

• Status: Unknown
• Conditions: Correctional Osteotomy
• Intervention / Treatment: Device: Programmed intermittent epidural bolus; Device: Continuous epidural infusion

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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; Other Names: PIEB
Active Comparator: CEI (Continuous epidural infusion); Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space 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; Other Names: standard, CEI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time for the first patient controlled rescue epidural bolus after surgery		48 hours after surgery
Number of patient-controlled rescue epidural bolus for 48 hours postoperatively		48 hours after surgery
Pain scores for 6 hours after surgery (VAS)	VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)	6 hours after surgery
Pain scores for 12 hours after surgery (VAS)	VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)	12 hours after surgery
Pain scores for 24 hours after surgery (VAS)	VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)	24 hours after surgery
Pain scores for 48 hours after surgery (VAS)	VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)	48 hours after surgery
Pain scores for 6 hours after surgery (r-FLACC)	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.	6 hours after surgery
Pain scores for 12 hours after surgery (r-FLACC)	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.	12 hours after surgery
Pain scores for 24 hours after surgery (r-FLACC)	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.	24 hours after surgery
Pain scores for 48 hours after surgery (r-FLACC)	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.	48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.	-% of patients with given intravenous additional narcotic analgesics; number of administrating intravenous additional narcotic analgesics per patient	48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.	-% of patients with given intravenous additional narcotic analgesics; total additional dose of intravenous narcotic analgesics per patient	48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.	-% of patients with given intravenous additional narcotic analgesics; measurement tool: Electronic Medical Record(including Drug administration history)	48 hours after surgery
A dull feeling the patient feels	A dull feeling the patient feels : yes or no	6 hours after surgery
A dull feeling the patient feels	A dull feeling the patient feels : yes or no	12 hours after surgery
A dull feeling the patient feels	A dull feeling the patient feels : yes or no	24 hours after surgery
A dull feeling the patient feels	A dull feeling the patient feels : yes or no	48 hours after surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4-2019-0418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No