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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01134289
First received: May 19, 2010
Last updated: June 4, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    foot temperature change from baseline

  • electrocardiogram [ Time Frame: 1 minute at intervals from baseline through end of procedure ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134289

Locations
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

No publications provided

Responsible Party: Clinical Research Institute, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01134289     History of Changes
Other Study ID Numbers: Seoul National Univ Hospital, H-0906-010-282
Study First Received: May 19, 2010
Last Updated: June 4, 2010
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Levobupivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013