Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 3:56 AM
Study NCT ID:
NCT04010032
Status:
UNKNOWN
Last Update Posted:
2019-12-12
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'triple (Participant, Care Provider, investigator)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in total amount of ropivacaine injected through epidural analgesia', 'timeFrame': '6 hours after surgery', 'description': 'The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively'}, {'measure': 'Difference in total amount of ropivacaine injected through epidural analgesia', 'timeFrame': '12 hours after surgery', 'description': 'The difference in the amount of ropivacaine injected into epidural space for 12 hours postoperatively'}, {'measure': 'Difference in total amount of ropivacaine injected through epidural analgesia', 'timeFrame': '24 hours after surgery', 'description': 'The difference in the amount of ropivacaine injected into epidural space for 24 hours postoperatively'}, {'measure': 'Difference in total amount of ropivacaine injected through epidural analgesia', 'timeFrame': '36 hours after surgery', 'description': 'The difference in the amount of ropivacaine injected into epidural space for 36 hours postoperatively'}, {'measure': 'Difference in total amount of ropivacaine injected through epidural analgesia', 'timeFrame': '48 hours after surgery', 'description': 'The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'The time for the first patient controlled rescue epidural bolus after surgery', 'timeFrame': '48 hours after surgery'}, {'measure': 'Number of patient-controlled rescue epidural bolus for 48 hours postoperatively', 'timeFrame': '48 hours after surgery'}, {'measure': 'Pain scores for 6 hours after surgery (VAS)', 'timeFrame': '6 hours after surgery', 'description': 'VAS(visual analogue scale) :0(no paine)\\~10(wort possible, unbearable, excruciating apin)'}, {'measure': 'Pain scores for 12 hours after surgery (VAS)', 'timeFrame': '12 hours after surgery', 'description': 'VAS(visual analogue scale) :0(no paine)\\~10(wort possible, unbearable, excruciating apin)'}, {'measure': 'Pain scores for 24 hours after surgery (VAS)', 'timeFrame': '24 hours after surgery', 'description': 'VAS(visual analogue scale) :0(no paine)\\~10(wort possible, unbearable, excruciating apin)'}, {'measure': 'Pain scores for 48 hours after surgery (VAS)', 'timeFrame': '48 hours after surgery', 'description': 'VAS(visual analogue scale) :0(no paine)\\~10(wort possible, unbearable, excruciating apin)'}, {'measure': 'Pain scores for 6 hours after surgery (r-FLACC)', 'timeFrame': '6 hours after surgery', 'description': '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.'}, {'measure': 'Pain scores for 12 hours after surgery (r-FLACC)', 'timeFrame': '12 hours after surgery', 'description': '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.'}, {'measure': 'Pain scores for 24 hours after surgery (r-FLACC)', 'timeFrame': '24 hours after surgery', 'description': '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.'}, {'measure': 'Pain scores for 48 hours after surgery (r-FLACC)', 'timeFrame': '48 hours after surgery', 'description': '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.'}, {'measure': 'Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.', 'timeFrame': '48 hours after surgery', 'description': '-% of patients with given intravenous additional narcotic analgesics\n\n* number of administrating intravenous additional narcotic analgesics per patient'}, {'measure': 'Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.', 'timeFrame': '48 hours after surgery', 'description': '-% of patients with given intravenous additional narcotic analgesics\n\n* total additional dose of intravenous narcotic analgesics per patient'}, {'measure': 'Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.', 'timeFrame': '48 hours after surgery', 'description': '-% of patients with given intravenous additional narcotic analgesics\n\n* measurement tool: Electronic Medical Record(including Drug administration history)'}, {'measure': 'A dull feeling the patient feels', 'timeFrame': '6 hours after surgery', 'description': 'A dull feeling the patient feels : yes or no'}, {'measure': 'A dull feeling the patient feels', 'timeFrame': '12 hours after surgery', 'description': 'A dull feeling the patient feels : yes or no'}, {'measure': 'A dull feeling the patient feels', 'timeFrame': '24 hours after surgery', 'description': 'A dull feeling the patient feels : yes or no'}, {'measure': 'A dull feeling the patient feels', 'timeFrame': '48 hours after surgery', 'description': 'A dull feeling the patient feels : yes or no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Correctional Osteotomy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Pediatric patients with between 4 and 13 years\n* 2\\. Patients scheduled for correctional osteotomy of the lower extremity\n* 3\\. Pediatric patients whose weight of 40kg of less\n\nExclusion Criteria:\n\n* 1\\. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)\n* 2\\. Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure\n* 3\\. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)'}, 'identificationModule': {'nctId': 'NCT04010032', 'briefTitle': 'The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients', 'orgStudyIdInfo': {'id': '4-2019-0418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIEB (Programmed intermittent epidural bolus)', 'description': 'bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection)', 'interventionNames': ['Device: Programmed intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CEI (Continuous epidural infusion)', 'description': 'Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device', 'interventionNames': ['Device: Continuous epidural infusion']}], 'interventions': [{'name': 'Programmed intermittent epidural bolus', 'type': 'DEVICE', 'otherNames': ['PIEB'], 'description': 'bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device', 'armGroupLabels': ['PIEB (Programmed intermittent epidural bolus)']}, {'name': 'Continuous epidural infusion', 'type': 'DEVICE', 'otherNames': ['standard, CEI'], 'description': 'Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device', 'armGroupLabels': ['CEI (Continuous epidural infusion)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Yong Seon Choi, MD, Ph.D', 'role': 'CONTACT', 'email': 'yschoi@yush.ac', 'phone': '82-2-2228-2412'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yong Seon Choi, MD., PhD.', 'role': 'CONTACT', 'email': 'YSCHOI@yuhs.ac', 'phone': '82-2-2228-2412'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}