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

U

University of Indonesia (UI)

Status

Completed

Conditions

Caesarian Section

Treatments

Procedure: Crossed leg sitting position

Study type

Interventional

Funder types

Other

Identifiers

NCT03054233
IndonesiaUAnes010

Details and patient eligibility

About

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

Full 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.

Enrollment

136 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

Obese
Experimental group
Description:
Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section
Treatment:
Procedure: Crossed leg sitting position
Non-obese
Experimental group
Description:
Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section
Treatment:
Procedure: Crossed leg sitting position

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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