Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-28 @ 12:18 AM
Study NCT ID:
NCT06497634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nause and vomiting', 'timeFrame': 'First 24 hours', 'description': 'Number of participants with nause and vomiting in first 24 hours'}, {'measure': 'Double vision', 'timeFrame': 'First 24 hours', 'description': 'Number of participants with double vision in first 24 hours'}, {'measure': 'Headache', 'timeFrame': 'First 24 hours', 'description': 'Number of participants with headache in first 24 hours'}], 'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter', 'timeFrame': 'ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet', 'description': 'The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet', 'description': 'The effect of needle type and size on blood pressure'}, {'measure': 'Hearth rate', 'timeFrame': 'Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet', 'description': 'The effect of needle type and size on hearth rate'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet', 'description': 'The effect of needle type and size on oxygen saturation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Anesthesia', 'Intracranial Pressure Change', 'Optic Nerve Sheath Diameter', 'Orthopedic Surgery', 'Cerebrospinal Fluid Leak']}, 'referencesModule': {'references': [{'pmid': '10925937', 'type': 'BACKGROUND', 'citation': 'Reina MA, de Leon-Casasola OA, Lopez A, De Andres J, Martin S, Mora M. An in vitro study of dural lesions produced by 25-gauge Quincke and Whitacre needles evaluated by scanning electron microscopy. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):393-402. doi: 10.1053/rapm.2000.7622.'}, {'pmid': '12770980', 'type': 'BACKGROUND', 'citation': 'Killer HE, Laeng HR, Flammer J, Groscurth P. Architecture of arachnoid trabeculae, pillars, and septa in the subarachnoid space of the human optic nerve: anatomy and clinical considerations. Br J Ophthalmol. 2003 Jun;87(6):777-81. doi: 10.1136/bjo.87.6.777.'}, {'pmid': '1419942', 'type': 'BACKGROUND', 'citation': 'Tarkkila PJ, Heine H, Tervo RR. Comparison of Sprotte and Quincke needles with respect to post dural puncture headache and backache. Reg Anesth. 1992 Sep-Oct;17(5):283-7.'}, {'pmid': '39465875', 'type': 'DERIVED', 'citation': 'Kumas Solak S, Demirgan S, Karali E, Selcan A. Effect of needle types and diameters using in spinal anesthesia on optic nerve sheath diameter: Prospective randomized study. Medicine (Baltimore). 2024 Oct 11;103(41):e40003. doi: 10.1097/MD.0000000000040003.'}]}, 'descriptionModule': {'briefSummary': 'The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.', 'detailedDescription': 'Optic nerve sheath diameter (ONSD) measured with US emerges as a standout intracranial pressure reflector among non-invasive modalities as a bed side assessment. Different types of needles used in spinal anesthesia cause different lesions in the dura. Lesions created by Quincke needles are small and clean-cut opening in the dural membrane, while those from Whitacre needles result in a more traumatic opening. Also it is known that CSF leakage increase when larger needles are used. As one of postspinal headache mechanism is decrease in the intracranial pressure, the investigators aim to investigate the ONSD changes reflecting intracranial pressure changes.\n\nParticipants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. ONSD measurements will be performed before spinal anesthesia as baseline; and 5 minutes, 15 minutes, 24 hours after spinal block, respectively. Also a measurement will be performed after opening of the surgical tourniquet. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I-II Risk Classification\n* Elective orthopedic lower extremity surgery\n* Using a tourniquet\n* Spinal anesthesia\n\nExclusion Criteria:\n\n* Bilateral tourniquet usage\n* History of orbital trauma\n* Optic nerve pathology\n* Glaucoma\n* Asthma\n* Coronary obstructive or pulmonary disease\n* Previous corneal or intraocular surgery\n* Increased intracranial pressure\n* Coagulopathy\n* Local site infection\n* Refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT06497634', 'briefTitle': 'Effect of Spinal Needle Type on Optic Nerve Sheath Diameter', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Bagcilar1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 25w (25 gauge Whitacre needle)', 'description': 'Spinal anesthesia will be performed with 25 G pencil point needle (Whitacre)', 'interventionNames': ['Procedure: 25 PP', 'Other: Optic Nerve Sheath Measurement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 25q (25 gauge Quincke needle)', 'description': 'Spinal anesthesia will be performed with 25 G sharp edge needle (Quincke)', 'interventionNames': ['Procedure: 25 Q', 'Other: Optic Nerve Sheath Measurement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 27q (27 gauge Quincke needle)', 'description': 'Spinal anesthesia will be performed with 27 G sharp edge needle (Quincke)', 'interventionNames': ['Procedure: 27 Q', 'Other: Optic Nerve Sheath Measurement']}], 'interventions': [{'name': '25 PP', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed in sitting position, with 25 G pencil point needle (Whitacre -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.', 'armGroupLabels': ['Group 25w (25 gauge Whitacre needle)']}, {'name': '25 Q', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed in sitting position, with 25 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.', 'armGroupLabels': ['Group 25q (25 gauge Quincke needle)']}, {'name': '27 Q', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed in sitting position, with 27 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.', 'armGroupLabels': ['Group 27q (27 gauge Quincke needle)']}, {'name': 'Optic Nerve Sheath Measurement', 'type': 'OTHER', 'description': 'Sonographic measurement of ONSD (EsaoteMyLabFive, Cenova, Italy) for all patients will be performed by a single experienced anesthesiologist. After a thin gel layer apply to the upper eyelid, the patient in the supine position and with the eyes closed, using a 6-13 MHz linear probe, optic sheath nerve measurement will be done 3 mm behind the optic globe, with a total of three measurements of which the final value will be recorded.The measurement will be repeated five times using US guidance at the following time points: T0 (pre-anesthesia), T1 (5 minutes after spinal block), T2 (15 minutes after spinal block, T3 (tourniquet opening), and T4 (24 hours after spinal block ) respectively.', 'armGroupLabels': ['Group 25q (25 gauge Quincke needle)', 'Group 25w (25 gauge Whitacre needle)', 'Group 27q (27 gauge Quincke needle)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Bagci̇lar', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SEZEN KUMAS SOLAK, MD', 'role': 'CONTACT', 'email': 'sezenkumassolak@gmail.com', 'phone': '+905055729494'}], 'facility': 'Bagcılar Training Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'sezen kumas solak, MD', 'role': 'CONTACT', 'email': 'sezenkumassolak@gmail.com', 'phone': '+905055729494'}], 'overallOfficials': [{'name': 'sezen kumas solak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bagcılar Training Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not share individual patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Sezen Kumaş Solak', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}