Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-05-19 @ 1:57 PM
Study NCT ID:
NCT02159560
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Uniport and Multiport Epidural Catheters in Post-surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phess@bidmc.harvard.edu', 'phone': '6176673112', 'title': 'Philip Hess', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '72 hours', 'eventGroups': [{'id': 'EG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Epidural Catheter Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'OG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'The primary outcome of the study will be the incidence of failed epidural analgesia, defined as the need to add intravenous opioids or halting or replacing the epidural catheter because of lack of pain control.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Receiving Supplemental Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'OG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'number of subjects receiving supplemental treatments required to maintain continual comfort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Dose of Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'OG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': 'Median dose (per hour) of medication required to maintain comfort', 'unitOfMeasure': 'ml per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'FG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}], 'periods': [{'title': 'Enrolled', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}]}, {'title': 'Analyzed', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'End Holed Catheter', 'description': 'Single holed, end holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'BG001', 'title': 'Three Holed Catheter', 'description': 'closed ended, three side holed epidural catheter\n\nEpidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-02-12', 'size': 820836, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-10T09:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patient, evaluator, statistician all blinded to assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blinded comparison of two epidural catheter designs'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2014-05-19', 'resultsFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-20', 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Dose of Medication', 'timeFrame': '72 hours', 'description': 'Median dose (per hour) of medication required to maintain comfort'}], 'primaryOutcomes': [{'measure': 'Epidural Catheter Failure', 'timeFrame': '72 hours', 'description': 'The primary outcome of the study will be the incidence of failed epidural analgesia, defined as the need to add intravenous opioids or halting or replacing the epidural catheter because of lack of pain control.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Receiving Supplemental Treatments', 'timeFrame': '72 hours', 'description': 'number of subjects receiving supplemental treatments required to maintain continual comfort'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Post-operative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that multi-port thoracic epidural catheters will provide superior pain relief when compared to uniport catheters for post-surgical patients.', 'detailedDescription': 'Epidural analgesia (pain relief) is an effective treatment for post-surgical acute pain. The factors that determine the effectiveness of pain relief with epidural analgesia have been studied almost exclusively in the lumbar (low back) spaces for obstetrics (childbirth). These factors include the design of the epidural catheter, the type and dose of medications, and the volume of solution used. One of the important issues specific to the catheter design is whether the tip has a one end-hole, or multiple side holes. The number of holes has been suggested to affect the spread of epidural anesthetic over time, especially with low volume solutions. This has been demonstrated in older, stiffer epidural catheter designs, but has not been shown to be true with the newer, flexible epidural catheters.\n\nThe thoracic (upper back) epidural analgesia is widely employed for a many types of surgical pain. While the mechanism of pain relief is similar to that in the lumbar space, there may be differences between the two sites. Firstly, thoracic catheters tend to use low volume, high concentration medication solutions, which likely do not spread as effectively. Secondly, the thoracic catheters often need to be used for prolonged periods of time. Whereas the typical obstetric epidural is used for less than 12 hours, the post-surgical catheter is typically required for one to three days (or more). Finally, the thoracic space is narrow, with a thinner thecal sac, which might promote a difference in the spread of epidural solution.\n\nThoracic epidural analgesia is routinely used to control post-operative pain for a wide variety of surgical procedures. Based on the improved effectiveness of the one end-hole flexible epidural catheter in obstetrics, this design is commonly used in thoracic epidural analgesia. It has been observed that thoracic epidurals are somewhat less effective after a period of time when compared to the effectiveness of labor epidurals. This may be in part due to the inappropriate assumption that the thoracic epidural space of a post-surgical patient is the same as the lumbar space of a parturient.\n\nThe investigators seek to determine whether there is a difference in the analgesia provided by a thoracic multi-port epidural catheter when compared to a thoracic uniport epidural catheter as measured by pain scores, medication given for breakthrough pain, and need to add intravenous opioids. As mentioned previously, these catheters have been studied extensively in laboring patients but there is a striking paucity of literature regarding how anesthetic solutions spread in the thoracic epidural spaces of non-pregnant post-surgical patients and how this may be affected by catheter type. If the hypothesis is supported by results, it may change the practice within the study institution, and possibly, on a much larger scale. This study may also provide a foundation for further research into the physiology of the thoracic epidural space, how it differs from the lumbar epidural space, and how a medication solution spreads within this unique space.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* Surgery in the thorax or upper abdomen\n* Age between 18 and 75\n* Expected use of epidural analgesia for \\>24 hours\n\nExclusion Criteria:\n\n* Contraindication to epidural catheterization\n* Chronic use of opioids\n* Chronic pain\n* Allergy to the standard medications used\n* Body Mass Index \\>40\n* Delirium\n* Dementia'}, 'identificationModule': {'nctId': 'NCT02159560', 'briefTitle': 'Uniport and Multiport Epidural Catheters in Post-surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Uniport and Multiport Epidural Catheters in Post-surgical Patients', 'orgStudyIdInfo': {'id': '2014P000085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'End holed catheter', 'description': 'Single holed, end holed epidural catheter', 'interventionNames': ['Device: Epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Three holed catheter', 'description': 'closed ended, three side holed epidural catheter', 'interventionNames': ['Device: Epidural catheter']}], 'interventions': [{'name': 'Epidural catheter', 'type': 'DEVICE', 'description': 'The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter', 'armGroupLabels': ['End holed catheter', 'Three holed catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Philip E Hess, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Obstetric Anesthesia', 'investigatorFullName': 'Phillip Hess', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}