Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03459105
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of needle passes', 'timeFrame': "Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)", 'description': 'the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin'}], 'secondaryOutcomes': [{'measure': 'Number of spinal needle insertion attempts', 'timeFrame': "Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)", 'description': 'the number of times the spinal needle was withdrawn from the skin and reinserted'}, {'measure': 'Time for identifying landmarks', 'timeFrame': '1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)', 'description': 'In group L, time from start of palpation to completion of the process, as declared by the anesthesiologist. In group U, time from placement of the ultrasound probe on the skin to the completion of markings.'}, {'measure': 'Time taken for performing spinal anesthetic', 'timeFrame': 'Intraoperative (from insertion of the needle to the completion of injection)', 'description': 'time from needle insertion to the completion of injection'}, {'measure': 'dermatome level of sensory block', 'timeFrame': '5, 10, 15 minutes after the completion of spinal anesthetic injection', 'description': 'thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab'}, {'measure': 'Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle', 'timeFrame': 'Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)', 'description': 'Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure'}, {'measure': 'Periprocedural pain', 'timeFrame': 'Patients will be asked immediately after the completion of spinal anesthesia', 'description': '11-point verbal rating scale (0=no pain, 10=most pain imaginable)'}, {'measure': 'Periprocedural discomfort score', 'timeFrame': 'Patients will be asked immediately after the completion of spinal anesthesia', 'description': '11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Spinal', 'Ultrasonography', 'Scoliosis']}, 'referencesModule': {'references': [{'pmid': '21572316', 'type': 'BACKGROUND', 'citation': 'Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia,\n* with ASA physical status classification I, II, III,\n* and with (1) or (2)\n\n 1. documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle \\> 10 degree)\n 2. previous history of lumbar spinal surgery\n\nExclusion Criteria:\n\n* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)\n* Patients with morbid cardiac diseases\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03459105', 'briefTitle': 'Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy', 'orgStudyIdInfo': {'id': '1801-107-917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound-assisted', 'description': 'Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.', 'interventionNames': ['Procedure: Ultrasound-assisted paramedian spinal anesthesia', 'Drug: 0.5% heavy bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Landmark-guided', 'description': 'Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.', 'interventionNames': ['Procedure: Landmark-guided spinal anesthesia', 'Drug: 0.5% heavy bupivacaine']}], 'interventions': [{'name': 'Ultrasound-assisted paramedian spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['sono-assisted'], 'description': 'A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.', 'armGroupLabels': ['Ultrasound-assisted']}, {'name': 'Landmark-guided spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['conventional'], 'description': 'Spinal anesthesia will be done using conventional landmark-guided technique.', 'armGroupLabels': ['Landmark-guided']}, {'name': '0.5% heavy bupivacaine', 'type': 'DRUG', 'otherNames': ['bupivacaine'], 'description': '0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.', 'armGroupLabels': ['Landmark-guided', 'Ultrasound-assisted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}