NCT01321684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

March 18, 2011

Last Update Submit

May 26, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time for the complete regression of pinprick spinal analgesia on the nondependent legs

    Sensory and motor blockade were evaluated within 3 hour of intrathecal injection

Interventions

The patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes.

the patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia

You may not qualify if:

  • Hemodynamically unstable patients
  • Lumbar disease
  • patients with back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 23, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations