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

February 15, 2017 updated by: Susilo Chandra, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Central Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese
Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section
Procedure: Crossed leg sitting position
Spinal anesthesia done in crossed leg sitting position
Experimental: Non-obese
Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section
Procedure: Crossed leg sitting position
Spinal anesthesia done in crossed leg sitting position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
The number of needle-bone contact
Time Frame: 2 months
The number of spinal needle-bone contact
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of blood vessel puncture incidence.
Time Frame: 2 months
The number of blood vessel puncture incidence by the spinal needle during insertion.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Susilo Chandra, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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