The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jin-Tae Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01321684

First received: March 18, 2011

Last updated: May 26, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 18, 2011
Last Updated Date	May 26, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2011)	Time for the complete regression of pinprick spinal analgesia on the nondependent legs [ Time Frame: Sensory and motor blockade were evaluated within 3 hour of intrathecal injection ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01321684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia
Official Title ^ICMJE	Not Provided
Brief Summary	For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in the middle of the subarachnoid space. This study was performed to assess if flexion of the vertebral column facilitates unilateral spinal anesthesia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Spinal Anesthesia
Intervention ^ICMJE	Other: lateral decubitus position with full spinal flexion The patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes. Other: lateral decubitus position without spinal flexion the patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia Exclusion Criteria: Hemodynamically unstable patients Lumbar disease patients with back pain
Gender	Male
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01321684
Other Study ID Numbers ^ICMJE	H-1006-100-322
Has Data Monitoring Committee	Yes
Responsible Party	Jin-Tae Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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