Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT07047469
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The severity of back pain in patients that will receive spinal anesthesia by median versus paramedian approach', 'timeFrame': '24 hours, 72 hours, and 1 week after spinal anesthesia.', 'description': 'pain measurement by numerical rating scale (NRS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia; Functional']}, 'referencesModule': {'references': [{'pmid': '35907825', 'type': 'BACKGROUND', 'citation': 'Zeng W, Shi Y, Zheng Q, Du S. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022 Jul 30;22(1):242. doi: 10.1186/s12871-022-01751-0.'}, {'pmid': '29628579', 'type': 'BACKGROUND', 'citation': 'Singh B, Sohal AS, Singh I, Goyal S, Kaur P, Attri JP. Incidence of Postspinal Headache and Low Backache Following the Median and Paramedian Approaches in Spinal Anesthesia. Anesth Essays Res. 2018 Jan-Mar;12(1):186-189. doi: 10.4103/aer.AER_139_17.'}, {'pmid': '31005435', 'type': 'BACKGROUND', 'citation': 'Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will perform orthopedic surgery\n* Physical state I or II according to ASA classification\n* Age between (18 - 50 )\n* Body mass index less than 30\n\nExclusion Criteria:\n\n* Patient refusal .\n* Local infection at the puncture site .\n* Allergy to any of the drugs to be administrated .\n* Old age patients\n* Obese patients\n* Previous spinal surgery .\n* Spinal stenosis .\n* Multiple sclerosis .\n* Coagulopathy.\n* Hypovolemia .\n* Systemic infection .\n* Aortic stenosis .\n* Spina bifida and back deformity .'}, 'identificationModule': {'nctId': 'NCT07047469', 'briefTitle': 'Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'Soh-Med--25-6-16MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (1): spinal anesthesia with median approach', 'description': 'patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques', 'interventionNames': ['Procedure: Group (1): spinal anesthesia with median approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (2): spinal anesthesia with paramedian approach', 'description': 'patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques', 'interventionNames': ['Procedure: Group (2): spinal anesthesia with paramedian approach']}], 'interventions': [{'name': 'Group (1): spinal anesthesia with median approach', 'type': 'PROCEDURE', 'description': 'patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques', 'armGroupLabels': ['Group (1): spinal anesthesia with median approach']}, {'name': 'Group (2): spinal anesthesia with paramedian approach', 'type': 'PROCEDURE', 'description': 'patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques', 'armGroupLabels': ['Group (2): spinal anesthesia with paramedian approach']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT', 'phone': '01090801900'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Areej M Abd Elkader, Resident', 'role': 'CONTACT', 'email': 'Mareej22@yahoo.com', 'phone': '01288811379'}, {'name': 'Ahmed E Abd Elrahman, Professor', 'role': 'CONTACT', 'phone': '01118011611'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University', 'investigatorFullName': 'Areej Mohamed Abdelkader', 'investigatorAffiliation': 'Sohag University'}}}}