Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section

Conditions
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Pregnancy, Caesarean Section

Intervention / Treatment
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* Procedure: Traditional sitting position
* Procedure: Pendant position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional sitting position<br>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. | Procedure: Traditional sitting position<br>* Subjects were set on traditional sitting position before spinal anesthesia begun.<br>|
| Experimental: Pendant position<br>Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun. | Procedure: Pendant position<br>* Subjects were set on pendant position before spinal anesthesia begun.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful spinal puncture attempt number | The number of attempt for the successful spinal puncture for each positions | 2 months | 
| The number of spinal needle-bone contact | The number of spinal needle-bone contact for each positions | 2 months | 
| Spinal puncture duration | the duration to perform spinal puncture for each positions | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal, anesthesia, pendant, spinal-bone contact, puncture