- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753660
Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia
April 28, 2016 updated by: Pryambodho Pryambodho, Indonesia University
Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- pregnant women aged 18-45 years old
- Body Mass Index (BMI) 18-35 kg/m2
- physical status American Society of Anesthesiologists (ASA) I-III
- planned to undergo cesarean section with spinal anesthesia and signed the informed consent form
Exclusion Criteria:
- Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
- pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
- Patient with eclampsia
- Patient with cardiovascular diseases
- Patient with scoliosis
- Patient with history of lumbar surgery
- Patient with unpalpable intervertebral space due to thick fatty tissue or edema.
Drop out criteria:
- spinal block was failed or only partial block
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional sitting position
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.
|
Subjects were set on traditional sitting position before spinal anesthesia begun.
|
Experimental: Pendant position
Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun.
|
Subjects were set on pendant position before spinal anesthesia begun.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful spinal puncture attempt number
Time Frame: 2 months
|
The number of attempt for the successful spinal puncture for each positions
|
2 months
|
The number of spinal needle-bone contact
Time Frame: 2 months
|
The number of spinal needle-bone contact for each positions
|
2 months
|
Spinal puncture duration
Time Frame: 2 months
|
the duration to perform spinal puncture for each positions
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pryambodho Pryambodho, Consultant, Indonesia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: Anesth Analg. 2009 Oct;109(4):1208.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
April 26, 2016
First Submitted That Met QC Criteria
April 26, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Estimate)
April 29, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- IndonesiaUAnes001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy, Caesarean Section
-
Brno University HospitalUniversity Hospital Olomouc; St. Anne's University Hospital Brno, Czech Republic and other collaboratorsCompletedCaesarean Section | PregnancyCzech Republic
-
Assiut UniversityUnknownCaesarean SectionEgypt
-
Taipei Medical University WanFang HospitalCompletedCaesarean SectionTaiwan
-
Sintetica SACross Research S.A.TerminatedUnplanned Caesarean SectionBelgium
-
Egyptian Society of Royal College of Obstetricians...UnknownCaesarean Section RateEgypt
-
Maimonides Medical CenterTerminatedCaesarean SectionUnited States
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknownCaesarean SectionNetherlands
-
Shanghai First Maternity and Infant HospitalUnknownCaesarean SectionChina
-
Minia UniversityCompletedCaesarean Section Rate | EgyptEgypt
Clinical Trials on Traditional sitting position
-
Assistance Publique - Hôpitaux de ParisCompletedEpidural Analgesia for Labour and DeliveryFrance
-
Indonesia UniversityCompletedAdult Patients With Spinal AnesthesiaIndonesia
-
Cairo UniversityCompleted
-
Vrije Universiteit BrusselCompletedGastro-oesophageal RefluxBelgium
-
Hospices Civils de LyonCompleted
-
University of FloridaTerminated
-
Centre Hospitalier Régional d'OrléansRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingNeurologic Disorder | Urodynamic ExamFrance
-
Wollo UniversityActive, not recruitingSeverty of HpotentionEthiopia
-
Anna OlczakCompleted