Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03054233
Enrollment
136
Registered
2017-02-15
Start date
2016-07-31
Completion date
2016-12-31
Last updated
2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarian Section

Keywords

spinal anesthesia, spinal-bone contact, caesarian section, crossed leg sitting position

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.

Interventions

PROCEDURECrossed leg sitting position

Spinal anesthesia done in crossed leg sitting position

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of successful spinal needle placement in the first attempt2 monthsThe number of successful spinal needle placement in the first attempt was recorded in yes/no method.
The number of needle-bone contact2 monthsThe number of spinal needle-bone contact

Secondary

MeasureTime frameDescription
The number of blood vessel puncture incidence.2 monthsThe number of blood vessel puncture incidence by the spinal needle during insertion.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026