Spinal AnesthesiaNCT01321684
The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia
A study testing lateral decubitus position with full spinal flexion and lateral decubitus position without spinal flexion in people with Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- lateral decubitus position with full spinal flexion and lateral decubitus position without spinal flexion
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia
Who cannot join
- Hemodynamically unstable patients
- Lumbar disease
- patients with back pain
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Anesthesia
- Being tested
- lateral decubitus position with full spinal flexion, lateral decubitus position without spinal flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral decubitus position with full spinal flexionOther
The patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes.
lateral decubitus position without spinal flexionOther
the patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for the complete regression of pinprick spinal analgesia on the nondependent legs
Measured: Sensory and motor blockade were evaluated within 3 hour of intrathecal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321684
- Sponsor's protocol ID
- H-1006-100-322
- Status last verified
- May 2012
- First submitted
- 18 Mar 2011
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01321684
- Acronym / sponsor ID
- H-1006-100-322
- Conditions
- Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia
Key exclusion criteria (3 listed)
- Hemodynamically unstable patients
- Lumbar disease
- patients with back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral decubitus position with full spinal flexionThe patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes. | Other | – |
| lateral decubitus position without spinal flexionthe patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral decubitus position with full spinal flexion and lateral decubitus position without spinal flexion in people with Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.