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OpenTrials
Completed

NCT Number: NCT02753660

Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia

The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

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 were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pregnant women aged 18-45 years old
  • Body Mass Index (BMI) 18-35 kg/m2
  • physical status American Society of Anesthesiologists (ASA) I-III
  • planned to undergo cesarean section with spinal anesthesia and signed the informed consent form

Exclusion criteria

  • Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
  • pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
  • Patient with eclampsia
  • Patient with cardiovascular diseases
  • Patient with scoliosis
  • Patient with history of lumbar surgery
  • Patient with unpalpable intervertebral space due to thick fatty tissue or edema.

Drop out criteria:

  • spinal block was failed or only partial block

Treatment and study plan

Traditional sitting position

Procedure

Subjects were set on traditional sitting position before spinal anesthesia begun.

Pendant position

Procedure

Subjects were set on pendant position before spinal anesthesia begun.

Primary outcomes

  1. Successful spinal puncture attempt number

    Time frame: 2 months

    The number of attempt for the successful spinal puncture for each positions

  2. The number of spinal needle-bone contact

    Time frame: 2 months

    The number of spinal needle-bone contact for each positions

  3. Spinal puncture duration

    Time frame: 2 months

    the duration to perform spinal puncture for each positions

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2016
Registry last updated
Apr 29, 2016

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.