Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 2:57 PM
Study NCT ID:
NCT01024868
Status:
COMPLETED
Last Update Posted:
2010-05-04
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Spread of Transversus Abdominis Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2010-05-03', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transversus Abdominis Plane Block'], 'conditions': ['Transversus Abdominis Plane Block']}, 'referencesModule': {'references': [{'pmid': '22450529', 'type': 'DERIVED', 'citation': 'Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.'}, {'pmid': '22381092', 'type': 'DERIVED', 'citation': 'Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.'}]}, 'descriptionModule': {'briefSummary': 'For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing abdominal surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40\n\nExclusion Criteria:\n\n* does not speak danish, does not consent, does not fulfill inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01024868', 'briefTitle': 'Assessment of Spread of Transversus Abdominis Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Assessment of Spread of Transversus Abdominis Plane Block After Administration of 20 ml Ropivacaine 0,5% Bilaterally', 'orgStudyIdInfo': {'id': 'TDTSG-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAP block', 'description': 'Patients before undergoing laparoscopic or other abdominal surgery', 'interventionNames': ['Drug: Ropivacaine 0,5%']}], 'interventions': [{'name': 'Ropivacaine 0,5%', 'type': 'DRUG', 'description': 'Injection of ropivacaine 0,5% 20 ml bilaterally before surgery', 'armGroupLabels': ['TAP block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev University Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Ann M Møller, dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Anja U. Mitchell', 'oldOrganization': 'Herlev University Hospital, Copenhagen'}}}}