Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block
park001
An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
2 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
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
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedJune 7, 2010
June 1, 2010
5 months
May 19, 2010
June 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Index of sympathetic block
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
1 minute at intervals from baseline through end of procedure
Secondary Outcomes (2)
skin temperature changes
1 minute at intervals during procedure
electrocardiogram
1 minute at intervals from baseline through end of procedure
Study Arms (2)
lumbar sympathetic block
ACTIVE COMPARATORUnilateral lumbar sympathetic blockade using chirocaine
contralateral side
NO INTERVENTIONInterventions
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
Eligibility Criteria
You may qualify if:
- Physically examined for complex regional pain syndrome on lower extremity,
- Scheduled for diagnostic lumbar sympathetic blockade.
You may not qualify if:
- Graded as ASA 3 or higher,
- Below 18 or above 70 years of age, or
- Had any other contraindication for regional anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 110744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 31, 2010
Study Start
September 1, 2009
Primary Completion
February 1, 2010
Last Updated
June 7, 2010
Record last verified: 2010-06