Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT01076894
Status:
COMPLETED
Last Update Posted:
2010-02-26
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-25', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at rest and on coughing after thoracic surgery', 'timeFrame': 'Pain during the first four postoperative days'}], 'secondaryOutcomes': [{'measure': 'pulmonary function (peak expiratory flow rate) after thoracic surgery', 'timeFrame': 'first four postoperative days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'thoracotomy', 'pulmonary function', 'epidural anesthesia', 'intercostal nerve block'], 'conditions': ['Thoracotomy']}, 'descriptionModule': {'briefSummary': 'Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.\n\nThus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection\n\nExclusion Criteria:\n\n* age\\<18 yr\n* any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac\n* lack of patient's cooperation\n* any type of chronic painful condition or current opioid use"}, 'identificationModule': {'nctId': 'NCT01076894', 'briefTitle': 'Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.', 'orgStudyIdInfo': {'id': 'EDA-ICB 198/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'epidural anesthesia', 'interventionNames': ['Procedure: epidural anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intercostal anesthesia', 'interventionNames': ['Procedure: intercostal anesthesia']}], 'interventions': [{'name': 'epidural anesthesia', 'type': 'PROCEDURE', 'description': 'In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.', 'armGroupLabels': ['epidural anesthesia']}, {'name': 'intercostal anesthesia', 'type': 'PROCEDURE', 'description': 'In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits', 'armGroupLabels': ['intercostal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universtity Clinic Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Michael Georgieff, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department for Anesthesiology University Clinic Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Anesthesiology', 'oldOrganization': 'University Clinic Ulm'}}}}