NCT04010032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

June 25, 2019

Last Update Submit

December 9, 2019

Conditions

Correctional Osteotomy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (17)

  • 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

  • Pain scores for 12 hours after surgery (VAS)

    12 hours after surgery

  • Pain scores for 24 hours after surgery (VAS)

    24 hours after surgery

  • +12 more secondary outcomes

Study Arms (2)

PIEB (Programmed intermittent epidural bolus)

EXPERIMENTAL

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

CEI (Continuous epidural infusion)

ACTIVE COMPARATOR

Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device

Device: Continuous epidural infusion

Interventions

Programmed intermittent epidural bolusDEVICE

bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device

Also known as: PIEB
PIEB (Programmed intermittent epidural bolus)
Continuous epidural infusionDEVICE

Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device

Also known as: standard, CEI
CEI (Continuous epidural infusion)

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

Central Study Contacts

Yong Seon Choi, MD., PhD.

CONTACT

82-2-2228-2412YSCHOI@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple (Participant, Care Provider, investigator)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 8, 2019

Study Start

January 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)