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

NCT ID: NCT02766829

Last Updated: 2016-05-10

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

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Adult Patients With Spinal Anesthesia

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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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.

Group Type EXPERIMENTAL

Cross leg sitting position

Intervention Type PROCEDURE

Subjects were set on cross leg sitting position before spinal anesthesia begun.

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.

Group Type ACTIVE_COMPARATOR

Traditional sitting position

Intervention Type PROCEDURE

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

Interventions

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Cross leg sitting position

Subjects were set on cross leg sitting position before spinal anesthesia begun.

Intervention Type PROCEDURE

Traditional sitting position

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Sidharta K. Manggala

Consultant, Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sidharta K Manggala, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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Other Identifiers

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IndonesiaUAnes007

Identifier Type: -

Identifier Source: org_study_id

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