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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

Tracking Information
First Submitted Date  ICMJE May 19, 2010
First Posted Date  ICMJE May 31, 2010
Last Update Posted Date June 7, 2010
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block
Official Title  ICMJE An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Complex Regional Pain Syndrome
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: lumbar sympathetic block
    Unilateral lumbar sympathetic blockade using chirocaine
    Intervention: Procedure: lumbar sympathetic block
  • No Intervention: contralateral side
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2010)
25
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01134289
Other Study ID Numbers  ICMJE Seoul National Univ Hospital
H-0906-010-282 ( Other Identifier: SeoulNUH )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Research Institute, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP