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

Study Overview
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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.

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

Conditions
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Adult Patients With Spinal Anesthesia

Intervention / Treatment
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* Procedure: Cross leg sitting position
* Procedure: Traditional sitting position


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLSP Group<br>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<br>* Subjects were set on cross leg sitting position before spinal anesthesia begun.<br>|
| Active Comparator: TSP Group<br>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<br>* Subjects were set on traditional sitting position before spinal anesthesia begun.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One shot successful spinal needle placement | The number of successful spinal needle placement in the first attempt | 7 months | 
| Needle-bone contact number | The number of needle-bone contact recorded. | 7 months | 
| The difficulty level of landmark palpation for injection | 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 | Complications recorded were post dural puncture headache, low back pain and neural trauma. | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal, anesthesia, sitting, cross leg, spinal-bone contact