Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 3:19 AM
Study NCT ID:
NCT07210892
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paramedian Incidence Angles in Spinal Anaesthesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of needle insertion attempts', 'timeFrame': 'From September 2025 to september 2026.'}], 'secondaryOutcomes': [{'measure': 'Number of needle redirections', 'timeFrame': 'From september 2025 to september 2028'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Submitted to Spinal Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '27598547', 'type': 'BACKGROUND', 'citation': 'Puigdellivol-Sanchez A, Reina MA, Sala-Blanch X, Pomes-Tallo J, Prats-Galino A. Pythagoras and Cosines: The skin-dural sac distance and optimal angles in paramedian spinal anesthesia. Clin Anat. 2016 Nov;29(8):1046-1052. doi: 10.1002/ca.22792. Epub 2016 Oct 6.'}, {'pmid': '39728676', 'type': 'RESULT', 'citation': 'Labandeyra H, Sala-Blanch X, Prats-Galino A, Puigdellivol-Sanchez A. Neuraxial Anesthesia and Risk of Root Damage: A 3D Ex Vivo Study. NeuroSci. 2024 Dec 3;5(4):623-634. doi: 10.3390/neurosci5040044.'}]}, 'descriptionModule': {'briefSummary': 'The objective here is to quantify the number of punctures and redirections during routine practice in the anesthesiology department, verify the final angle of incidence and the sac-skin distance by ultrasound, and determine the optimal, maximum, and minimum angles that would have allowed successful punctures. The objective is also to correlate ultrasound and plain X-ray distances, if available. These angles would then be inferred in advance in patients who must undergo spinal anesthesia, assessing whether this prior estimate reduces the number of punctures and redirections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patients requiring spinal anaesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: patients submitted to spinal anaesthesia -\n\nExclusion Criteria: none\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07210892', 'briefTitle': 'Paramedian Incidence Angles in Spinal Anaesthesia.', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Paramedian Incidence Angles in Spinal Anaesthesia.', 'orgStudyIdInfo': {'id': 'HCB/2018/1236'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1. Observational', 'description': 'Description of usual needle insertion attempts and redirections.', 'interventionNames': ['Other: Measurement of needle insertion angles']}], 'interventions': [{'name': 'Measurement of needle insertion angles', 'type': 'OTHER', 'description': 'Individualization of needle insertion angle depending on the skin to dural sac distance', 'armGroupLabels': ['Phase 1. Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Puigdellívol-Sánchez', 'role': 'CONTACT', 'email': 'apuigdellivol@cst.cat', 'phone': '935884555'}, {'name': 'Alberto Prats-Galino', 'role': 'CONTACT', 'email': 'aprats@ub.edu', 'phone': '934021900'}], 'facility': 'APuigdellivolSanchez', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Anna Puigdellívol-Sánchez, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'apuigdellivol@ub.edu', 'phone': '+34-93-5884555'}, {'name': 'Alberto Prats-Galino, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'aprats@ub.edu', 'phone': '+34-93-4021900'}], 'overallOfficials': [{'name': 'Alberto Prats-Galino, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'University of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Anna Puigdellívol Sánchez', 'investigatorFullName': 'Anna Puigdellívol-Sánchez', 'investigatorAffiliation': 'University of Barcelona'}}}}