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

Not Applicable

Completed

• Conditions: Caesarian Section
• Interventions: Procedure: Crossed leg sitting position

• Registration Number: NCT03054233
• Lead Sponsor: Indonesia University

Brief Summary

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

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 Timeline

• Study Start: 2016-07
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-15
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese	Crossed leg sitting position	Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section
Non-obese	Crossed leg sitting position	Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section

Primary Outcome Measures

Name	Time	Method
Number of successful spinal needle placement in the first attempt	2 months	The number of successful spinal needle placement in the first attempt was recorded in yes/no method.
The number of needle-bone contact	2 months	The number of spinal needle-bone contact

Secondary Outcome Measures

Name	Time	Method
The number of blood vessel puncture incidence.	2 months	The number of blood vessel puncture incidence by the spinal needle during insertion.

Trial Locations

Locations (2)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Central Jakarta, DKI Jakarta, Indonesia