Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT02544269
Status:
TERMINATED
Last Update Posted:
2017-05-05
First Post:
2015-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cardiac output', 'timeFrame': 'Up to 1 hour', 'description': 'Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.'}], 'secondaryOutcomes': [{'measure': 'Time for performance of nerve blocks', 'timeFrame': 'At time of nerve block performance', 'description': 'Time range (in minutes) from first insertion to last withdrawal of nerve block needle.'}, {'measure': 'Success rate of nerve blocks', 'timeFrame': '1 day'}, {'measure': 'Change of cardiac stroke volume', 'timeFrame': 'Up to 1 hour', 'description': 'Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Change of systemic vascular resistance', 'timeFrame': 'Up to 1 hour', 'description': 'Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Change of mean arterial pressure', 'timeFrame': 'Up to 1 hour', 'description': 'Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Change of central venous oxygen saturation', 'timeFrame': 'Up to 1 hour', 'description': 'Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Maximum plasma concentration of ropivacaine', 'timeFrame': '80 minutes', 'description': 'Arterial blood sampling at 20, 40, 60 and 80 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Change of plasma concentration of lactate', 'timeFrame': '60 minutes', 'description': 'Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine.'}, {'measure': 'Cumulated peroperative propofol dose', 'timeFrame': 'Up to 2 hours'}, {'measure': 'Cumulated peroperative opioid dose', 'timeFrame': 'Up to 2 hours'}, {'measure': 'Cumulated postoperative opioid dose', 'timeFrame': 'Up to 24 hours'}, {'measure': 'Time from end of operation to first opioid dose', 'timeFrame': 'Up to 24 hours'}, {'measure': 'Surgeons self reported satisfaction with anesthesia', 'timeFrame': 'Up to 2 hours', 'description': 'Numeric rating scale: 0-10'}, {'measure': 'Patients worst pain during surgery', 'timeFrame': 'Up to 2 hours', 'description': 'Numeric rating scale: 0-10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lumbosacral plexus blockade', 'Continuous spinal anesthesia', 'Hemodynamics'], 'conditions': ['Total Hip Replacement']}, 'descriptionModule': {'briefSummary': 'The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.', 'detailedDescription': 'Patients for total hip replacement will be randomized for surgical anesthesia with either lumbosacral plexus blockade or continuous spinal anesthesia. All patients will receive central venous, arterial and spinal catheters. Hemodynamics will be monitored with transpulmonary thermodilution and pulse contour analysis. Perineural injection of study medicine around the lumbar and sacral plexus will be performed guided by ultrasound and nerve stimulation. Study medicine will be injected in divided doses in the spinal catheter. Treatment will be blinded using double-dummy technique. After the first intrathecal dose of study medicine, the hemodynamic response will be monitored for 60 minutes. Patients will then be transferred to the operating room, where total hip replacement will be performed in lumbosacral plexus blockade or spinal anesthesia according to randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for total hip replacement at Aarhus University Hospital\n* Age \\>= 50 years\n* American Society of Anesthesiologists physical status classification score I-III\n* Informed consent\n\nExclusion Criteria:\n\n* Lack of ability to cooperate\n* Lack of ability to speak Danish\n* Chronic pain, that demands opioid treatment. Not inkl. hip pain.\n* Previous venous thromboembolic event\n* Previous major back surgery\n* Severe cardiopulmonary disease (NYHA class 4)\n* Severe untreated hypertension (systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 110 mm Hg)\n* Obesity (BMI \\> 35 kg/m\\^2)\n* Pregnancy\n* Allergy towards the used local analgetics\n* Current treatment with amiodarone or verapamil'}, 'identificationModule': {'nctId': 'NCT02544269', 'briefTitle': 'Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'HIP/FUSION#1'}, 'secondaryIdInfos': [{'id': '2015-003498-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumbosacral plexus blockade', 'description': 'Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural', 'interventionNames': ['Procedure: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous spinal anesthesia', 'description': 'Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal', 'interventionNames': ['Procedure: Bupivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'PROCEDURE', 'description': 'Lumbosacral plexus blockade with ropivacaine.', 'armGroupLabels': ['Lumbosacral plexus blockade']}, {'name': 'Bupivacaine', 'type': 'PROCEDURE', 'description': 'Regional anesthesia with bupivacaine titrated to the lowest effective dose', 'armGroupLabels': ['Continuous spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Center for Planlagt Kirurgi', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}], 'overallOfficials': [{'name': 'Niels D Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Dept. of Clinical Medicine'}, {'name': 'Thomas F Bendtsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital, Dept. of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymized data will be made available through Danish Data Archive.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Regionshospitalet Silkeborg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}