Correctional OsteotomyNCT04010032
The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
A study testing Programmed intermittent epidural bolus and Continuous epidural infusion in people with Correctional Osteotomy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Correctional Osteotomy
- What is being tested?
- Programmed intermittent epidural bolus and Continuous epidural infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
Yong Seon Choi, MD, Ph.D, 82-2-2228-2412, yschoi@yush.ac
About this study
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.
- Conditions
- Correctional Osteotomy
- Being tested
- Programmed intermittent epidural bolus, Continuous epidural infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed intermittent epidural bolusDevice
Also called PIEB
bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device
Continuous epidural infusionDevice
Also called standard, CEI
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours after surgery
Secondary outcomes (17)
The time for the first patient controlled rescue epidural bolus after surgery
Measured: 48 hours after surgery
Number of patient-controlled rescue epidural bolus for 48 hours postoperatively
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 48 hours after surgery
A dull feeling the patient feels
A dull feeling the patient feels : yes or no
Measured: 6 hours after surgery
A dull feeling the patient feels
A dull feeling the patient feels : yes or no
Measured: 12 hours after surgery
A dull feeling the patient feels
A dull feeling the patient feels : yes or no
Measured: 24 hours after surgery
A dull feeling the patient feels
A dull feeling the patient feels : yes or no
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startJan 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correctional OsteotomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010032
- Sponsor's protocol ID
- 4-2019-0418
- Status last verified
- Dec 2019
- First submitted
- 25 Jun 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04010032
- Acronym / sponsor ID
- 4-2019-0418
- Conditions
- Correctional Osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIEB (Programmed intermittent epidural bolus) | Experimental | Device: Programmed intermittent epidural bolusbolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) |
| CEI (Continuous epidural infusion) | Active comparator | Device: Continuous epidural infusionContinuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed intermittent epidural bolusAlso: PIEBbolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device | Device | PIEB (Programmed intermittent epidural bolus) |
| Continuous epidural infusionAlso: standard, CEIContinuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device | Device | CEI (Continuous epidural infusion) |
Primary outcome
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
17 secondary outcomes
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
Pain scores for 12 hours after surgery (VAS)
Time frame: 12 hours after surgery
Pain scores for 24 hours after surgery (VAS)
Time frame: 24 hours after surgery
Pain scores for 48 hours after surgery (VAS)
Time frame: 48 hours after surgery
Pain scores for 6 hours after surgery (r-FLACC)
Time frame: 6 hours after surgery
Pain scores for 12 hours after surgery (r-FLACC)
Time frame: 12 hours after surgery
Pain scores for 24 hours after surgery (r-FLACC)
Time frame: 24 hours after surgery
Pain scores for 48 hours after surgery (r-FLACC)
Time frame: 48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
Time frame: 48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
Time frame: 48 hours after surgery
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
Time frame: 48 hours after surgery
A dull feeling the patient feels
Time frame: 6 hours after surgery
A dull feeling the patient feels
Time frame: 12 hours after surgery
A dull feeling the patient feels
Time frame: 24 hours after surgery
A dull feeling the patient feels
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed intermittent epidural bolus and Continuous epidural infusion in people with Correctional Osteotomy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Seon Choi, MD., PhD. (82-2-2228-2412, YSCHOI@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in total amount of ropivacaine injected through epidural analgesia (time frame: 6 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.