Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women

Study Overview
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Brief Summary
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The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean 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 sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

Official Title
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Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section

Conditions
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Caesarian Section

Intervention / Treatment
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* Procedure: Crossed leg sitting position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position. Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form Exclusion Criteria: Subjects with contraindications for spinal anesthesia Subjects with fetal's head trapped, umbilical prolapse, and foot presentation Subjects with pre-eclampsia Subjects with cardiovascular diseases Subjects with scoliosis Subjects with recent lumbal surgery history Subjects who cannot sit in crossed leg sitting position. Drop out criteria: Subjects with worsening conditions before spinal anesthesia Subjects with failed spinal needle insertion and thus received general anesthesia Subjects with twin pregnancy Subjects drop out the study.

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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No

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 |
| --- | --- |
| Experimental: Obese<br>Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section | Procedure: Crossed leg sitting position<br>* Spinal anesthesia done in crossed leg sitting position<br>|
| Experimental: Non-obese<br>Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section | Procedure: Crossed leg sitting position<br>* Spinal anesthesia done in crossed leg sitting position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful spinal needle placement in the first attempt | The number of successful spinal needle placement in the first attempt was recorded in yes/no method. | 2 months | 
| The number of needle-bone contact | The number of spinal needle-bone contact | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of blood vessel puncture incidence. | The number of blood vessel puncture incidence by the spinal needle during insertion. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, spinal-bone contact, caesarian section, crossed leg sitting position