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

University of Indonesia (UI)

Status: Completed

Conditions: Pregnancy, Caesarean Section

Treatments: Procedure: Pendant position; Procedure: Traditional sitting position

Study type: Interventional

Funder types: Other

Identifiers

NCT02753660

IndonesiaUAnes001

Details and patient eligibility

About

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.

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 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.

Enrollment: 308 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Traditional sitting position

Active Comparator group

Description:

Patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun.

Treatment:

Procedure: Traditional sitting position

Pendant position

Experimental group

Description:

Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun.

Treatment:

Procedure: Pendant position