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Clinical Trials/NCT02753660
NCT02753660
Completed
Not Applicable

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

Indonesia University0 sites308 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy, Caesarean Section
Sponsor
Indonesia University
Enrollment
308
Primary Endpoint
Successful spinal puncture attempt number
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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 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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
October 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pryambodho Pryambodho

Consultant, Anesthesiologist

Indonesia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Successful spinal puncture attempt number

Time Frame: 2 months

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

The number of spinal needle-bone contact

Time Frame: 2 months

The number of spinal needle-bone contact for each positions

Spinal puncture duration

Time Frame: 2 months

the duration to perform spinal puncture for each positions

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