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

Study Overview
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Brief Summary
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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.

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

Conditions
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Correctional Osteotomy

Intervention / Treatment
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* Device: Programmed intermittent epidural bolus
* Device: Continuous epidural infusion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIEB (Programmed intermittent epidural bolus)<br>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<br>* bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device<br>* Other names: PIEB;|
| Active Comparator: CEI (Continuous epidural infusion)<br>Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device | Device: Continuous epidural infusion<br>* Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device<br>* Other names: standard, CEI;|

What is the study measuring?
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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 |