Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)

June 4, 2010 updated by: Seoul National University Hospital

An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110744
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute at intervals from baseline through end of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin temperature changes
Time Frame: 1 minute at intervals during procedure
foot temperature change from baseline
1 minute at intervals during procedure
electrocardiogram
Time Frame: 1 minute at intervals from baseline through end of procedure
heart rate variability measurement
1 minute at intervals from baseline through end of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Estimate)

June 7, 2010

Last Update Submitted That Met QC Criteria

June 4, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seoul National Univ Hospital
  • H-0906-010-282 (Other Identifier: SeoulNUH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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