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

Indonesia University136 enrolled

Overview

The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

136

Conditions

Caesarian Section

Interventions

Crossed leg sitting positionPROCEDURE

Spinal anesthesia done in crossed leg sitting position

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (2)

Cipto Mangunkusumo Central National Hospital

Central Jakarta, DKI Jakarta, Indonesia

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: 2 months

The number of needle-bone contact

The number of spinal needle-bone contact

Time frame: 2 months

Secondary Outcomes

The number of blood vessel puncture incidence.

The number of blood vessel puncture incidence by the spinal needle during insertion.

Time frame: 2 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.