Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-10 @ 11:20 PM
Study NCT ID:
NCT01760161
Status:
TERMINATED
Last Update Posted:
2015-05-12
First Post:
2012-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'whyStopped': 'No signal on pain-score', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thermoanalgesia at dermatome-level th6-th12', 'timeFrame': '1 hour after bilateral dual transversus abdominis plane block'}, {'measure': 'Plasma-ropivacain level', 'timeFrame': '15, 30, 60, 120 and 240 mins after the block'}], 'primaryOutcomes': [{'measure': 'Pain-score on numerical rating scale', 'timeFrame': '4 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Administration of opioids', 'timeFrame': 'The first 24 hours after surgery.'}, {'measure': 'Pain-score on numerical rating scale', 'timeFrame': '8 hours after surgery'}, {'measure': 'Pain-score on numerical rating scale', 'timeFrame': '24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'opioid consumption', 'termanalgesia', 'plasmaropivacain level'], 'conditions': ['Pain Treatment', 'Robotic Assisted Laparoscopic Surgery', 'Bilateral Dual Transversus Abdominis Plane Block']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.', 'detailedDescription': 'After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.\n\nThe investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.\n\nAlso a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.\n\nThe investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for robotic assisted laparoscopis surgery\n* acceptance to participate\n\nExclusion Criteria:\n\n* allergies to local analgetics\n* daily use of strong opioids'}, 'identificationModule': {'nctId': 'NCT01760161', 'briefTitle': 'Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '20120042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacain', 'description': 'Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic potassium chloride', 'description': 'Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.', 'interventionNames': ['Drug: Isotonic potassium chloride']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block', 'armGroupLabels': ['Ropivacain']}, {'name': 'Isotonic potassium chloride', 'type': 'DRUG', 'description': 'Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.', 'armGroupLabels': ['Isotonic potassium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Region Nord', 'country': 'Denmark', 'facility': 'Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anestetist', 'investigatorFullName': 'Nils Bjerregaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}