Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position

May 9, 2016 updated by: Sidharta K. Manggala, Indonesia University

Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery

The study aimed to compare successful spinal needle placement between crossed leg sitting position and traditional sitting position in patients underwent urology surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were randomly divided into CLSP Group for crossed leg sitting position (n=105) and TSP Group for traditional sitting position (n=106). Non-invasive blood pressure (NIBP) monitor, eletrocardiography (ECG), oxygen nasal cannula and pulse-oxymetry was set on the subjects in the operation room. Baseline information was recorded. Spinal anesthesia was done by anesthesiology registrars that have done 50 spinal anesthesia procedures and have been explained about the protocol of spinal anesthesia injection in this study (to avoid bias). Outcome measures were the number of successful spinal needle placement in the first attempt, the difficulty level of landmark palpation for injection, and the number of needle-bone contact. Data was analyzed by SPSS (Statistical Package for Social Scientist) using Chi-Square test, Fisher Exact test, and Kolmogorov-Smirnov test. Significance value used was 5% with 80% power.

Study Type

Interventional

Enrollment (Actual)

211

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
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central 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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects aged 18-60 years old-
  • subjects with ASA physical status I-III who were planned to undergo urology surgery with spinal anesthesia
  • Subjects who have been explained about the study, have agreed to enroll and have signed the informed consent form

Exclusion Criteria:

  • uncooperative subjects
  • subjects with relative and absolute contraindications to spinal anesthesia (coagulation disorders, thrombocytopenia, increases intracranial pressure, severe hypovolemia, severe heart valve disorders, local infection at the injection site, allergy toward local anesthetic agents, significant anatomical disorder of the spine, wound/scar on the lumbal area)
  • subjects with body mass index (BMI) > 32 kg/m2

Drop out criteria:

  • subjects who requestes to drop out of the study
  • subjects in need of emergency treatment during spinal anesthesia procedure
  • subjects with more than nine times redirected spinal needle (failed spinal anesthesia procedure).

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: CLSP Group
Those with cross leg sitting position: patients sit with both their knees flexed medially, hip flexed, resulting in pelvic leaning posteriorly and reducing lumbal lordosis.
Procedure: Cross leg sitting position
Subjects were set on cross leg sitting position before spinal anesthesia begun.
Active Comparator: TSP Group
Those with 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.
Procedure: Traditional sitting position
Subjects were set on traditional sitting position before spinal anesthesia begun.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One shot successful spinal needle placement
Time Frame: 7 months
The number of successful spinal needle placement in the first attempt
7 months
Needle-bone contact number
Time Frame: 7 months
The number of needle-bone contact recorded.
7 months
The difficulty level of landmark palpation for injection
Time Frame: 7 months
the difficulty level of landmark palpation for injection were assessed as easy or difficult.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal needle placement complications
Time Frame: 7 months
Complications recorded were post dural puncture headache, low back pain and neural trauma.
7 months

Collaborators and Investigators

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

Sponsor

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

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes007

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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