Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-11 @ 11:15 AM
Study NCT ID:
NCT02753660
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful spinal puncture attempt number', 'timeFrame': '2 months', 'description': 'The number of attempt for the successful spinal puncture for each positions'}, {'measure': 'The number of spinal needle-bone contact', 'timeFrame': '2 months', 'description': 'The number of spinal needle-bone contact for each positions'}, {'measure': 'Spinal puncture duration', 'timeFrame': '2 months', 'description': 'the duration to perform spinal puncture for each positions'}]}, 'conditionsModule': {'keywords': ['spinal, anesthesia, pendant, spinal-bone contact, puncture'], 'conditions': ['Pregnancy, Caesarean Section']}, 'referencesModule': {'references': [{'pmid': '12094920', 'type': 'BACKGROUND', 'citation': 'de Filho GR, Gomes HP, da Fonseca MH, Hoffman JC, Pederneiras SG, Garcia JH. Predictors of successful neuraxial block: a prospective study. Eur J Anaesthesiol. 2002 Jun;19(6):447-51. doi: 10.1017/s0265021502000716.'}, {'pmid': '19608828', 'type': 'BACKGROUND', 'citation': 'Fisher KS, Arnholt AT, Douglas ME, Vandiver SL, Nguyen DH. A randomized trial of the traditional sitting position versus the hamstring stretch position for labor epidural needle placement. Anesth Analg. 2009 Aug;109(2):532-4. doi: 10.1213/ane.0b013e3181ac6c79.'}, {'pmid': '24790901', 'type': 'BACKGROUND', 'citation': 'Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.'}, {'pmid': '24783134', 'type': 'BACKGROUND', 'citation': 'Shabanian G, Saadat M. A position for administration of difficult spinal anesthesia. J Clin Diagn Res. 2014 Mar;8(3):190-1. doi: 10.7860/JCDR/2014/5881.4198. Epub 2014 Mar 15. No abstract available.'}, {'pmid': '11573586', 'type': 'BACKGROUND', 'citation': 'Grau T, Leipold RW, Horter J, Conradi R, Martin E, Motsch J. The lumbar epidural space in pregnancy: visualization by ultrasonography. Br J Anaesth. 2001 Jun;86(6):798-804. doi: 10.1093/bja/86.6.798.'}, {'pmid': '9589547', 'type': 'BACKGROUND', 'citation': 'Tekeoglu I, Adak B, Bozkurt M, Gurbuzoglu N. Distraction of lumbar vertebrae in gravitational traction. Spine (Phila Pa 1976). 1998 May 1;23(9):1061-3; discussion 1064. doi: 10.1097/00007632-199805010-00019.'}, {'pmid': '22923823', 'type': 'BACKGROUND', 'citation': 'Shankar H, Rajput K, Murugiah K. Correlation between spinous process dimensions and ease of spinal anaesthesia. Indian J Anaesth. 2012 May;56(3):250-4. doi: 10.4103/0019-5049.98769.'}, {'pmid': '12526150', 'type': 'BACKGROUND', 'citation': 'Brooks RR, Oudekerk C, Olson RL, Daniel C, Vacchiano C, Maye J. The effect of spinal introducer needle use on postoperative back pain. AANA J. 2002 Dec;70(6):449-52.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.', 'detailedDescription': 'Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women aged 18-45 years old\n* Body Mass Index (BMI) 18-35 kg/m2\n* physical status American Society of Anesthesiologists (ASA) I-III\n* planned to undergo cesarean section with spinal anesthesia and signed the informed consent form\n\nExclusion Criteria:\n\n* Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)\n* pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,\n* Patient with eclampsia\n* Patient with cardiovascular diseases\n* Patient with scoliosis\n* Patient with history of lumbar surgery\n* Patient with unpalpable intervertebral space due to thick fatty tissue or edema.\n\nDrop out criteria:\n\n\\- spinal block was failed or only partial block'}, 'identificationModule': {'nctId': 'NCT02753660', 'briefTitle': 'Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional sitting position', 'description': 'Patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun.', 'interventionNames': ['Procedure: Traditional sitting position']}, {'type': 'EXPERIMENTAL', 'label': 'Pendant position', 'description': 'Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun.', 'interventionNames': ['Procedure: Pendant position']}], 'interventions': [{'name': 'Traditional sitting position', 'type': 'PROCEDURE', 'description': 'Subjects were set on traditional sitting position before spinal anesthesia begun.', 'armGroupLabels': ['Traditional sitting position']}, {'name': 'Pendant position', 'type': 'PROCEDURE', 'description': 'Subjects were set on pendant position before spinal anesthesia begun.', 'armGroupLabels': ['Pendant position']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pryambodho Pryambodho, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Anesthesiologist', 'investigatorFullName': 'Pryambodho Pryambodho', 'investigatorAffiliation': 'Indonesia University'}}}}