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

Not Applicable

• Conditions: Correctional Osteotomy
• Interventions: Device: Programmed intermittent epidural bolus; Device: Continuous epidural infusion

• Registration Number: NCT04010032
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-08
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-12
• Study Start: 2020-01
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIEB (Programmed intermittent epidural bolus)	Programmed intermittent epidural bolus	bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection)
CEI (Continuous epidural infusion)	Continuous epidural infusion	Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device

Primary Outcome Measures

Name	Time	Method
Difference in total amount of ropivacaine injected through epidural analgesia	48 hours after surgery	The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
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)	6 hours after surgery	VAS(visual analogue scale) :0(no paine)\~10(wort possible, unbearable, excruciating apin)
Pain scores for 48 hours after surgery (VAS)	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)	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 (VAS)	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)	24 hours after surgery	VAS(visual analogue scale) :0(no paine)\~10(wort possible, unbearable, excruciating apin)
Pain scores for 12 hours after surgery (r-FLACC)	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)	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)	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.	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	48 hours after surgery	A dull feeling the patient feels : yes or no

Trial Locations

Locations (1)

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