Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 9:24 AM
Study NCT ID:
NCT01305603
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2011-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2011-02-28', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of local anesthetic evaluated by MR scanning', 'timeFrame': '30 minutes after administering the TAP blocks'}], 'secondaryOutcomes': [{'measure': 'Spread of anesthetized frontal dermatomes', 'timeFrame': '30 minutes after administering the TAP blocks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '20175754', 'type': 'BACKGROUND', 'citation': 'Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to investigate, in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.', 'detailedDescription': 'There has been much debate as to what extent the classical TAP block will anesthetize more than the frontal dermatomes (TH10-Th12/L1). Some cadaver studies have been performed with injection of dye in the classical TAP. However, it is still not clear whether a single injection of local anesthetic in the classical TAP block position will reach the more cephalad and medial intercostal TAP plexus (Th6-Th9). In this study the investigators use MR scanning and ultrasonography to investigate in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male\n* 18 years old or more\n* had no previous abdominal surgery\n* no regular medication\n* no coagulation disorders\n* no claustrophobia\n\nExclusion Criteria:\n\n* if the volunteer is not able to accept an uncomplicated administration of a classical (single) or dual TAP block'}, 'identificationModule': {'nctId': 'NCT01305603', 'briefTitle': 'Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning', 'orgStudyIdInfo': {'id': 'BBH-USG-PNB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dual TAP block', 'description': 'Dual TAP block on one side on the abdomen. Classical (or single) TAP on the contra lateral side of the abdomen; supplemented with a sham injection to ensure double blindness.', 'interventionNames': ['Drug: Bupivacaine', 'Procedure: Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classical (or single) TAP block', 'description': 'Dual TAP block on one side on the abdomen. Classical (or single) TAP on the contra lateral side of the abdomen; supplemented with a sham injection to ensure double blindness', 'interventionNames': ['Drug: Bupivacaine', 'Procedure: Injection']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Local anesthetic'], 'description': 'On both sides of the abdomen 30 ml of bupivacaine 2.5 mg/ml will be injected. This is a total of 60 ml of bupivacaine 2.5 mg/ml.', 'armGroupLabels': ['Classical (or single) TAP block', 'Dual TAP block']}, {'name': 'Injection', 'type': 'PROCEDURE', 'otherNames': ['Nerve blocks'], 'description': 'Injection under ultrasound-guidance', 'armGroupLabels': ['Classical (or single) TAP block', 'Dual TAP block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Capital Region of Denmark', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jens B Neimann, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Anesthesia, Bispebjerg Hospital, Copenhagen University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jens Børglum Neimann, MD, PhD, MBA, Consultant Anesthetist, Bispebjerg Hospital, Copenhagen University Hospital, Department of Anesthesia and Intensive Care Medicine, Bispebjerg Bakke 23, DK-2400 Copenhagen NV, Denmark', 'investigatorFullName': 'Jens Borglum Neimann', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}