Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT01669018
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1', 'timeFrame': '30 minutes after injection of local anesthetic'}], 'secondaryOutcomes': [{'measure': 'Plasma lidocaine level (mcg/mL)', 'timeFrame': '0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic', 'description': 'Chromatography analysis'}, {'measure': 'Block performance time', 'timeFrame': 'From start of probe on the skin until injection of local anesthetic is completed'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Immediately after completion of injection of local anesthetic'}, {'measure': 'Mean arterial blood pressure (MAP)', 'timeFrame': '5 minutes after completion of injection of local anesthetic', 'description': 'Absolute measure and relative change from pre-block measure'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Block performance time period', 'description': 'Estimated as incremental cost-effectiveness ratio'}, {'measure': 'Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)', 'timeFrame': '30 minutes after completed injection of local anesthetic'}, {'measure': 'Sensory blockade of the femoral nerve (cold, warmth, touch, pain)', 'timeFrame': '30 minutes after completion of injection of local anesthetic'}, {'measure': 'Motor blockade of the femoral nerve', 'timeFrame': '40 minutes after completion of injection of the local anesthetic'}, {'measure': 'Motor blockade of the obturator nerve', 'timeFrame': '40 minutes after completion of injection of the local anesthetic'}, {'measure': 'Perineural spread of local anesthetic (with contrast) estimated with MRI', 'timeFrame': '60 minutes after completion of injection of local anesthetic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Fracture']}, 'descriptionModule': {'briefSummary': 'Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.\n\nThe most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.\n\nThe investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.\n\nThis randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.\n\nThe hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* ASA I (American Society of Anesthesiologists physical status classification)\n\nExclusion Criteria:\n\n* volunteers who are not able to cooperate\n* volunteers who do not understand and speak danish\n* daily use of analgesics\n* allergy to local analgesics or contrast agents\n* abuse of medicine or alcohol\n* volunteers with technical impediments of the planned interventions'}, 'identificationModule': {'nctId': 'NCT01669018', 'acronym': 'SSPS', 'briefTitle': 'Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus', 'orgStudyIdInfo': {'id': 'SSPS-1-10-72-366-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar ultrasound trident (LUT)', 'description': 'Lumbar plexus block using LUT technique', 'interventionNames': ['Procedure: Lumbar plexus block using LUT technique']}, {'type': 'EXPERIMENTAL', 'label': 'Supra Sacral Parallel Shift (SSPS)', 'description': 'Lumbar plexus block using SSPS technique', 'interventionNames': ['Procedure: Lumbar plexus block using SSPS technique']}], 'interventions': [{'name': 'Lumbar plexus block using LUT technique', 'type': 'PROCEDURE', 'description': 'Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.', 'armGroupLabels': ['Lumbar ultrasound trident (LUT)']}, {'name': 'Lumbar plexus block using SSPS technique', 'type': 'PROCEDURE', 'description': 'Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.', 'armGroupLabels': ['Supra Sacral Parallel Shift (SSPS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Anesthesiology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Else Tønnesen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Health, Aarhus University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant anesthetist, associate professor', 'investigatorFullName': 'Thomas F. Bendtsen', 'investigatorAffiliation': 'University of Aarhus'}}}}