Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00373633
Status:
TERMINATED
Last Update Posted:
2014-08-15
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'terminated due to diminishing frequency of thorocotomies and slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain control-visual analog pain score', 'timeFrame': 'post surgery monitoring'}], 'secondaryOutcomes': [{'measure': 'respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities', 'timeFrame': 'post surgery monitoring'}]}, 'conditionsModule': {'keywords': ['THoracic Surgery', 'thoracic epidural', 'epidural', 'thoracotomy', 'intercostal nerve block', 'intercostal', 'nerve block'], 'conditions': ['THoracotomy']}, 'descriptionModule': {'briefSummary': 'We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.', 'detailedDescription': 'The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups\\[Figure 1\\]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral thoracotomy\n* Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy\n\nExclusion Criteria:\n\n* Bilateral thoracotomy\n* Planned bilateral thoracotomy\n* Planned chest wall resection\n* Planned combined thoracotomy and laparotomy procedure\n* VATS procedure without conversion to unilateral thoracotomy\n* Emergency operation\n* Critically ill patients\n* Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility\n* Patients who are unable to give informed consent\n* Patients with preoperative chronic back or chest wall pain\n* Empyema or other infective condition increasing the risk of epidural infection\n* Coagulopathy\n* Decision of the surgeon or anesthesiologist, or choice of the patient\n* Infection at site of epidural placement\n* Patients with other co morbidities which exclude thoracic epidural placement\n* Patients under the age of 18 years'}, 'identificationModule': {'nctId': 'NCT00373633', 'briefTitle': 'Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain', 'orgStudyIdInfo': {'id': 'VCU 011906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous extra-pleural intercostal local anesthesia', 'description': 'intra-operatively placed extrapleural intercostal catheter', 'interventionNames': ['Procedure: Extrapleural Intercostal Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Epidural', 'description': 'gold standard', 'interventionNames': ['Procedure: Thoracic Epidural']}], 'interventions': [{'name': 'Thoracic Epidural', 'type': 'PROCEDURE', 'description': 'Gold standard for post thoracotomy pain', 'armGroupLabels': ['Thoracic Epidural']}, {'name': 'Extrapleural Intercostal Catheter', 'type': 'PROCEDURE', 'description': 'Continuous extra-pleural intercostal local anesthesia', 'armGroupLabels': ['Continuous extra-pleural intercostal local anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Mark Nelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virgina Commonwealth University, Dept of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'I-Flow', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}