Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-03 @ 5:55 AM
Study NCT ID:
NCT03496259
Status:
TERMINATED
Last Update Posted:
2022-02-03
First Post:
2018-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On-Q Pump vs Epidural for Postoperative Pain Control in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient, family and clinical care team (nurses, residents, physician assistants) will be blinded, as well as the research team collecting outcomes. The surgeons (including primary investigator) will not be blinded as will be placing the device.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Poor recruitment, one of investigators left institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-04-05', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Additional narcotic use', 'timeFrame': '3 days', 'description': 'Mg of additional narcotics used for 3 post-operative days'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '3 days', 'description': 'Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days'}, {'measure': 'Days to ambulation', 'timeFrame': '0-5 days', 'description': 'The first post-operative day that patients are ambulating outside the room will be noted'}, {'measure': 'Days to initiation of regular diet', 'timeFrame': '0-5 days', 'description': 'The first post-operative day of initiation of a regular diet will be noted'}, {'measure': 'Development of postoperative infection', 'timeFrame': '0-5 days', 'description': 'Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain, on-Q pump, epidural, children'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. Post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. There are no studies comparing these regimens in children. The purpose of this study is to compare postoperative pain control of the two strategies.', 'detailedDescription': 'The study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. The patient and treating team will be blinded to the pain control device. The primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (UTI, wound infection or pneumonia), and hospital length of stay. Outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight \\> 5kg\n* Age younger than 19 years of age\n* Planned abdominal, pelvic or thoracic operation for an oncologic indication\n\nExclusion Criteria:\n\n* Patients deemed inappropriate for placement of epidural by anesthesiologist\n* Minimally invasive operation\n* Biopsy through limited incision\n* History of chronic narcotic or opioid use\n* History of drug abuse'}, 'identificationModule': {'nctId': 'NCT03496259', 'briefTitle': 'On-Q Pump vs Epidural for Postoperative Pain Control in Children', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery', 'orgStudyIdInfo': {'id': 'H-42606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'On-Q Group', 'description': 'Patients in this group will have an On-Q pump placed at the end of the operation', 'interventionNames': ['Device: On-Q pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural Group', 'description': 'Patients in this group will have an epidural catheter placed at the end of the operation', 'interventionNames': ['Device: Epidural catheter']}], 'interventions': [{'name': 'On-Q pump', 'type': 'DEVICE', 'description': 'Type of pain control device used', 'armGroupLabels': ['On-Q Group']}, {'name': 'Epidural catheter', 'type': 'DEVICE', 'description': 'Type of pain control device used', 'armGroupLabels': ['Epidural Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bindi Naik-Mathuria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bindi Naik-Mathuria', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}