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

NCT ID: NCT02753660

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Pregnancy, Caesarean Section

Keywords

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spinal, anesthesia, pendant, spinal-bone contact, puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Traditional sitting position

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.

Group Type ACTIVE_COMPARATOR

Traditional sitting position

Intervention Type PROCEDURE

Subjects were set on traditional sitting position before spinal anesthesia begun.

Pendant position

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

Group Type EXPERIMENTAL

Pendant position

Intervention Type PROCEDURE

Subjects were set on pendant position before spinal anesthesia begun.

Interventions

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Traditional sitting position

Subjects were set on traditional sitting position before spinal anesthesia begun.

Intervention Type PROCEDURE

Pendant position

Subjects were set on pendant position before spinal anesthesia begun.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Pryambodho Pryambodho

Consultant, Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pryambodho Pryambodho, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

References

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de Filho GR, Gomes HP, da Fonseca MH, Hoffman JC, Pederneiras SG, Garcia JH. Predictors of successful neuraxial block: a prospective study. Eur J Anaesthesiol. 2002 Jun;19(6):447-51. doi: 10.1017/s0265021502000716.

Reference Type BACKGROUND
PMID: 12094920 (View on PubMed)

Fisher KS, Arnholt AT, Douglas ME, Vandiver SL, Nguyen DH. A randomized trial of the traditional sitting position versus the hamstring stretch position for labor epidural needle placement. Anesth Analg. 2009 Aug;109(2):532-4. doi: 10.1213/ane.0b013e3181ac6c79.

Reference Type BACKGROUND
PMID: 19608828 (View on PubMed)

Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.

Reference Type BACKGROUND
PMID: 24790901 (View on PubMed)

Shabanian G, Saadat M. A position for administration of difficult spinal anesthesia. J Clin Diagn Res. 2014 Mar;8(3):190-1. doi: 10.7860/JCDR/2014/5881.4198. Epub 2014 Mar 15. No abstract available.

Reference Type BACKGROUND
PMID: 24783134 (View on PubMed)

Grau T, Leipold RW, Horter J, Conradi R, Martin E, Motsch J. The lumbar epidural space in pregnancy: visualization by ultrasonography. Br J Anaesth. 2001 Jun;86(6):798-804. doi: 10.1093/bja/86.6.798.

Reference Type BACKGROUND
PMID: 11573586 (View on PubMed)

Tekeoglu I, Adak B, Bozkurt M, Gurbuzoglu N. Distraction of lumbar vertebrae in gravitational traction. Spine (Phila Pa 1976). 1998 May 1;23(9):1061-3; discussion 1064. doi: 10.1097/00007632-199805010-00019.

Reference Type BACKGROUND
PMID: 9589547 (View on PubMed)

Shankar H, Rajput K, Murugiah K. Correlation between spinous process dimensions and ease of spinal anaesthesia. Indian J Anaesth. 2012 May;56(3):250-4. doi: 10.4103/0019-5049.98769.

Reference Type BACKGROUND
PMID: 22923823 (View on PubMed)

Brooks RR, Oudekerk C, Olson RL, Daniel C, Vacchiano C, Maye J. The effect of spinal introducer needle use on postoperative back pain. AANA J. 2002 Dec;70(6):449-52.

Reference Type BACKGROUND
PMID: 12526150 (View on PubMed)

Other Identifiers

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IndonesiaUAnes001

Identifier Type: -

Identifier Source: org_study_id