Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT05777694
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postdural Punction Headache After Ceserian Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The prospective randomized study was randomized into 3 groups:\n\nGroup 1: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( Pencan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 2: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( Atraucan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 3: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( Pencan ® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pospective randomize study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PDPH and spinal needle', 'timeFrame': 'postoperatively 15 days. The hospital was visited on the first day and information was obtained by calling in the following days. Patients with PDPH were evaluated as mild (1-3), moderate (4-7), severe (8-10) according to the Lybecker classification.', 'description': 'The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache.'}], 'secondaryOutcomes': [{'measure': 'Treatment response of patients with PDPH', 'timeFrame': 'postoperatively 15 days, The hospital was visited on the first day and information was obtained by calling in the following days. Oral drugs used in the treatment and recommendations were noted.', 'description': 'Response rate of patients with PDPH to conservative and medical treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'obstetric anesthesia', 'spinal anaesthesia', 'postdural punction headache'], 'conditions': ['Postdural Puncture Headache', 'Regional Anesthesia Morbidity', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '34141426', 'type': 'RESULT', 'citation': 'Chekol B, Yetneberk T, Teshome D. Prevalence and associated factors of post dural puncture headache among parturients who underwent cesarean section with spinal anesthesia: A systemic review and meta-analysis, 2021. Ann Med Surg (Lond). 2021 Jun 2;66:102456. doi: 10.1016/j.amsu.2021.102456. eCollection 2021 Jun.'}, {'pmid': '30070060', 'type': 'RESULT', 'citation': 'Lee SI, Sandhu S, Djulbegovic B, Mhaskar RS. Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta-analysis. J Evid Based Med. 2018 Aug;11(3):136-144. doi: 10.1111/jebm.12311. Epub 2018 Aug 1.'}, {'pmid': '33993346', 'type': 'RESULT', 'citation': 'Mowafy SMS, Ellatif SEA. Effectiveness of nebulized dexmedetomidine for treatment of post-dural puncture headache in parturients undergoing elective cesarean section under spinal anesthesia: a randomized controlled study. J Anesth. 2021 Aug;35(4):515-524. doi: 10.1007/s00540-021-02944-6. Epub 2021 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effect of spinal needle type on postdural puncture headache in patients who will undergo cesarean section.\n\nThe main question\\[s\\] it aims to answer are:\n\n\\[Does spinal needle thickness affect postdural puncture headache?\\]\n\n\\[What is the response of patients who develop postdural puncture headache to treatment?\\] In cases accepting cesarean section operation under spinal anesthesia, different tables were used with spinal needles, and it will be questioned whether headache will develop in the first 15 days postoperatively. Postdural puncture headache after surgery will be described.', 'detailedDescription': 'Our study was designed as a prospective randomized study. Patients aged 20-50 years who accepted cesarean section under elective spinal anesthesia were included in the study. randomized into 3 groups with 250 patients in each group:\n\nGroup 1: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( Pencan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 2: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( Atraucan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 3: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( Pencan ® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Postdural puncture headache (PDPH) was evaluated by visiting patients who were discharged to the service after spinal anesthesia in the hospital for 24 hours, and by calling them within 15 days after discharge. Conservative and medical treatment was recommended for patients who developed PDPH, and the response of the patients to treatment was evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III\n\nExclusion Criteria:\n\n* Pregnant women who do not accept spinal anesthesia and who are contraindicated for spinal anesthesia Morbid obesity(BMI\\>40) Coagulopaty ASA 4 Clinically known local anesthetic allergy'}, 'identificationModule': {'nctId': 'NCT05777694', 'briefTitle': 'Postdural Punction Headache After Ceserian Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '2021-297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: 25 gauge spinal needle', 'description': 'Group 1: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( Pencan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany)', 'interventionNames': ['Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle', 'Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle', 'Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: 26 gauge spinal needle', 'description': 'Group 2: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( Atraucan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany)', 'interventionNames': ['Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle', 'Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle', 'Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: 27 gauge spina needle', 'description': 'Group 3: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( Pencan ® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany)', 'interventionNames': ['Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle', 'Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle', 'Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle']}], 'interventions': [{'name': 'Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle', 'type': 'PROCEDURE', 'description': 'the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache', 'armGroupLabels': ['Group 1: 25 gauge spinal needle', 'Group 2: 26 gauge spinal needle', 'Group 3: 27 gauge spina needle']}, {'name': 'Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle', 'type': 'PROCEDURE', 'description': 'the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache', 'armGroupLabels': ['Group 1: 25 gauge spinal needle', 'Group 2: 26 gauge spinal needle', 'Group 3: 27 gauge spina needle']}, {'name': 'Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle', 'type': 'PROCEDURE', 'description': 'the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache', 'armGroupLabels': ['Group 1: 25 gauge spinal needle', 'Group 2: 26 gauge spinal needle', 'Group 3: 27 gauge spina needle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Basaksehir', 'country': 'Turkey (Türkiye)', 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Duygu Akyol, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient data will be kept confidential.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Duygu Akyol', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}