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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)

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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
Sponsor:
Information provided by:
Seoul National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Procedure: lumbar sympathetic block Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

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Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • 0.25% bupivacaine (Chirocaine, Abbott, Elverum, Norway)
  • C-arm (OEC 9800 plus, GE Medical Systems, Salt Lake City, UT)
  • Chiba needle (Cook Inc., Bloomington, IN)
No Intervention: contralateral side


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. skin temperature changes [ Time Frame: 1 minute at intervals during procedure ]
    foot temperature change from baseline

  2. electrocardiogram [ Time Frame: 1 minute at intervals from baseline through end of procedure ]
    heart rate variability measurement


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physically examined for complex regional pain syndrome on lower extremity,
  • Scheduled for diagnostic lumbar sympathetic blockade.

Exclusion Criteria:

  • Graded as ASA 3 or higher,
  • Below 18 or above 70 years of age, or
  • Had any other contraindication for regional anesthesia.
Contacts and Locations
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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


Locations
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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    soo02@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Clinical Research Institute, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01134289    
Other Study ID Numbers: Seoul National Univ Hospital
H-0906-010-282 ( Other Identifier: SeoulNUH )
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010
Keywords provided by Seoul National University Hospital:
complex regional pain syndrome
lumbar sympathetic blockade
photoplethysmography
diagnostic lumbar sympathetic blockade
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents