Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-04-15 @ 8:29 AM
Study NCT ID:
NCT00653367
Status:
WITHDRAWN
Last Update Posted:
2012-02-24
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Chronic Pain After Nerve Section During Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (NRS)', 'timeFrame': '3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'QST parameters (sensory thresholds to cool/Warmth)', 'timeFrame': '3 months postoperatively'}, {'measure': 'Social well-being (HADS / PCS)', 'timeFrame': '3 months postoperatively'}, {'measure': 'Function (pain impairment of Activities of Daily Life)', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoracotomy', 'Nerve section', 'QST', 'Quantitative Sensory Test', 'Muscle sparing Posterolateral thoracotomy', 'Chest', 'Wall', 'Surgical', 'Incision', 'Tumors or cancer of the lung'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included for anterior or lateral thoracotomy\n\nExclusion Criteria:\n\n* Unable to give consent due to age, cognitive reduction or otherwise\n* Neurological disease or symptoms affection thoracic area\n* Chronic pain prior to surgery\n* Inability to supply the patient with an epidural catheter\n* Pneumonectomy\n* Prolonged infection at surgical site\n* Invasive tumor growth\n* Need for repeated surgery at site'}, 'identificationModule': {'nctId': 'NCT00653367', 'briefTitle': 'Evaluation of Chronic Pain After Nerve Section During Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Post Thoracotomy Pain After Nerve Section', 'orgStudyIdInfo': {'id': 'RH-EKPF-2008-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NS', 'description': 'Nerve section of intercostal nerve during surgery', 'interventionNames': ['Procedure: Nerve section']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control'}], 'interventions': [{'name': 'Nerve section', 'type': 'PROCEDURE', 'description': 'Intercostal nerve is divided during surgery', 'armGroupLabels': ['NS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Section for Surgical Pathophysiology 4074', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kim Wildgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section for Surgical Pathophysiology 4074'}, {'name': 'Henrik Kehlet, MD, Phd, Pro', 'role': 'STUDY_CHAIR', 'affiliation': 'Section for Surgical Pathophysiology 4074'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'MD Kim Wildgaard', 'oldOrganization': 'Section for Surgical Pathophysiology 4074'}}}}