Clinical Trials Directory

Trials / Completed

CompletedNCT02766829

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
211 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
PROCEDURECross leg sitting positionSubjects were set on cross leg sitting position before spinal anesthesia begun.
PROCEDURETraditional sitting positionSubjects were set on traditional sitting position before spinal anesthesia begun.

Timeline

Start date
2015-03-01
Primary completion
2015-10-01
Completion
2015-10-01
First posted
2016-05-10
Last updated
2016-05-10

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT02766829. Inclusion in this directory is not an endorsement.