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Completed

NCT Number: NCT02766829

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cross leg sitting position

Procedure

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

Traditional sitting position

Procedure

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

Primary outcomes

  1. One shot successful spinal needle placement

    Time frame: 7 months

    The number of successful spinal needle placement in the first attempt

  2. Needle-bone contact number

    Time frame: 7 months

    The number of needle-bone contact recorded.

  3. 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.

Secondary outcomes

  1. Spinal needle placement complications

    Time frame: 7 months

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 10, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.