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

Not Applicable

Completed

• Conditions: Pregnancy, Caesarean Section

• Registration Number: NCT02753660
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful spinal puncture attempt number	2 months	The number of attempt for the successful spinal puncture for each positions
The number of spinal needle-bone contact	2 months	The number of spinal needle-bone contact for each positions
Spinal puncture duration	2 months	the duration to perform spinal puncture for each positions