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

Indonesia University211 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

211

Conditions

Adult Patients With Spinal Anesthesia

Interventions

Cross leg sitting positionPROCEDURE

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

Traditional sitting positionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Locations (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

One shot successful spinal needle placement

The number of successful spinal needle placement in the first attempt

Time frame: 7 months

Needle-bone contact number

The number of needle-bone contact recorded.

Time frame: 7 months

The difficulty level of landmark palpation for injection

the difficulty level of landmark palpation for injection were assessed as easy or difficult.

Time frame: 7 months

Secondary Outcomes

Spinal needle placement complications

Complications recorded were post dural puncture headache, low back pain and neural trauma.

Time frame: 7 months

Data from ClinicalTrials.gov

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