Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-04-05 @ 5:52 AM
Study NCT ID:
NCT01764932
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2013-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2013-01-02', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Post procedure at 48 hours', 'description': 'Patient satisfaction 48 hrs after the end of surgery'}], 'primaryOutcomes': [{'measure': 'Presumed intervertebral level of epidural catheter', 'timeFrame': 'During procedure', 'description': 'At the time of thoracic epidural catheter insertion'}], 'secondaryOutcomes': [{'measure': 'Radiologic confirmation of epidural catheter placement', 'timeFrame': 'Post procedure within one week.', 'description': 'Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.'}, {'measure': 'Change in Numeric Rating Pain Score from baseline', 'timeFrame': '1, 24 and 48 hrs', 'description': '1, 24, and 48 hrs after the end of the surgery.'}]}, 'conditionsModule': {'conditions': ['Patients Undergoing Thoracic Surgery', 'Patients Undergoing Upper Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.\n\nPrevious studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.', 'detailedDescription': 'Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.\n\nBeneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18- 80 years old patients\n* Patients undergoing thoracic surgery\n* Patients undergoing upper abdominal surgery\n\nExclusion Criteria:\n\n* Severe Aortic Valve stenosis\n* Active Neurologic Disease\n* Allergy to lidocaine or bupivacaine\n* Allergy to iodine-based contrast\n* Cutaneous Disorders at epidural insertion site\n* Preoperative impaired coagulation status\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01764932', 'briefTitle': 'Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Chicago Anesthesia Pain Specialists'}, 'officialTitle': 'Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging', 'orgStudyIdInfo': {'id': 'Advocate-IRB-5242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Thoracic epidural catheter insertion', 'description': 'Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery', 'interventionNames': ['Procedure: Fluoroscopic imaging']}], 'interventions': [{'name': 'Fluoroscopic imaging', 'type': 'PROCEDURE', 'description': 'Contrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections.', 'armGroupLabels': ['Thoracic epidural catheter insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Illinois Masonic Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kenneth D Candido, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chicago Anesthesia Pain Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chicago Anesthesia Pain Specialists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center', 'investigatorFullName': 'Kenneth D Candido', 'investigatorAffiliation': 'Chicago Anesthesia Pain Specialists'}}}}