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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Information provided by:
Seoul National University Hospital Identifier:
First received: May 19, 2010
Last updated: June 4, 2010
Last verified: June 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 Intervention Phase
Complex Regional Pain Syndrome Procedure: lumbar sympathetic block Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 25
Study Start Date: September 2009
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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.
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Please refer to this study by its identifier: 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   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Clinical Research Institute, Seoul National University Hospital Identifier: NCT01134289     History of Changes
Other Study ID Numbers: Seoul National Univ Hospital
H-0906-010-282 ( Other Identifier: SeoulNUH )
Study First Received: May 19, 2010
Last Updated: June 4, 2010

Keywords provided by Seoul National University Hospital:
complex regional pain syndrome
lumbar sympathetic blockade
diagnostic lumbar sympathetic blockade

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 21, 2017