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Completed

NCT Number: NCT03054233

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

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital, Central Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crossed leg sitting position

Procedure

Spinal anesthesia done in crossed leg sitting position

Primary outcomes

  1. Number of successful spinal needle placement in the first attempt

    Time frame: 2 months

    The number of successful spinal needle placement in the first attempt was recorded in yes/no method.

  2. The number of needle-bone contact

    Time frame: 2 months

    The number of spinal needle-bone contact

Secondary outcomes

  1. The number of blood vessel puncture incidence.

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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