Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01134289|
Recruitment Status : Unknown
Verified June 2010 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : May 31, 2010
Last Update Posted : June 7, 2010
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.
The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome||Procedure: lumbar sympathetic block||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||February 2010|
Active Comparator: lumbar sympathetic block
Unilateral lumbar sympathetic blockade using chirocaine
Procedure: lumbar sympathetic block
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
|No Intervention: contralateral side|
- Index of sympathetic block [ Time Frame: 1 minute at intervals from baseline through end of procedure ]
change of slope of signals of the alternative current and the direct current from foot
The baseline is defined as the point of surgical drap.
The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection
- skin temperature changes [ Time Frame: 1 minute at intervals during procedure ]foot temperature change from baseline
- electrocardiogram [ Time Frame: 1 minute at intervals from baseline through end of procedure ]heart rate variability measurement
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): NCT01134289
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine, Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110744|
|Contact: Soo Young Park, MD 82-2-2072-0881 email@example.com|