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

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ClinicalTrials.gov Identifier: NCT02766829
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sidharta K. Manggala, Indonesia University

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

Condition or disease Intervention/treatment Phase
Adult Patients With Spinal Anesthesia Procedure: Cross leg sitting position Procedure: Traditional sitting position Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery
Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: 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.
Procedure: Cross leg sitting position
Subjects were set on cross leg sitting position before spinal anesthesia begun.

Active Comparator: 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.
Procedure: Traditional sitting position
Subjects were set on traditional sitting position before spinal anesthesia begun.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Spinal needle placement complications [ Time Frame: 7 months ]
    Complications recorded were post dural puncture headache, low back pain and neural trauma.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766829


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Sidharta K Manggala, Consultant Indonesia University

Publications:

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Responsible Party: Sidharta K. Manggala, Consultant, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT02766829    
Other Study ID Numbers: IndonesiaUAnes007
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Keywords provided by Sidharta K. Manggala, Indonesia University:
spinal
anesthesia
sitting
cross leg
spinal-bone contact
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs