Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-25 @ 10:30 PM
Study NCT ID:
NCT01679392
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating Properties of the Transversus Abdominis Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2012-08-27', 'studyFirstSubmitQcDate': '2012-09-05', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous analgesic distribution', 'timeFrame': '90 min', 'description': 'Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration'}], 'secondaryOutcomes': [{'measure': 'Muscular affection of the transversus abdominis plane block', 'timeFrame': '90 min', 'description': 'Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions'}, {'measure': 'Reproducibility of the transversus abdominis plane block', 'timeFrame': 'At least 2 days', 'description': 'Reproducibility of the transversus abdominis plane block with respect to:\n\n1. Cutaneous analgesic distribution\n2. Abdominal wall muscle affection measured in the same individual separated by at least 2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transversus abdominis plane block', 'Ultrasound guided nerve block'], 'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:\n\n1. Cutaneous analgesic distribution\n2. Muscular affection\n3. Reproducibility'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable\n* American society of anesthesiologists classification 1 or 2\n* Written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years\n* American society of anesthesiologists classification above 2\n* Body weight below 50 kg\n* Body mass index \\> 35 kg/m2\n* Previous abdominal surgery\n* Acute or chronic pain\n* Use of pain medication less than 24 h prior to study start\n* Allergy to local anesthetics\n* Pregnancy\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT01679392', 'briefTitle': 'A Study Investigating Properties of the Transversus Abdominis Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'H-1-2011-030'}, 'secondaryIdInfos': [{'id': '2011-004719-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine', 'description': 'Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)', 'armGroupLabels': ['Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerød Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Kion Bo Støving, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillerod Hospital, Denmark'}, {'name': 'Charlotte Rosenstock, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hillerod Hospital, Denmark'}, {'name': 'Kai Lange, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hillerod Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kai Henrik Wiborg Lange', 'investigatorAffiliation': 'Hillerod Hospital, Denmark'}}}}