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

NCT03054233 | Completed

• 1 other identifier: IndonesiaUAnes010
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Caesarian Section

Keywords

spinal anesthesia; spinal-bone contact; caesarian section; crossed leg sitting position

Outcome Measures

Primary Outcomes (2)

• Number of successful spinal needle placement in the first attempt

  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

  The number of spinal needle-bone contact

  2 months

Secondary Outcomes (1)

• The number of blood vessel puncture incidence.

  2 months

Study Arms (2)

Obese

EXPERIMENTAL

Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section

Procedure: Crossed leg sitting position

Non-obese

EXPERIMENTAL

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

Interventions

Crossed leg sitting position PROCEDURE

Spinal anesthesia done in crossed leg sitting position

Non-obese; Obese

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Cipto Mangunkusumo Central National Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

Location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

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Study Officials

• Susilo Chandra

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

ID (2)