park001: Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01134289

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2010

Arms and Interventions

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

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

Primary Outcome Measures

Index of sympathetic block [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 [1 minute at intervals during procedure]
foot temperature change from baseline
electrocardiogram [1 minute at intervals from baseline through end of procedure]
heart rate variability measurement