Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

NCT ID: NCT01134289

Last Updated: 2010-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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

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Conditions

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Complex Regional Pain Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lumbar sympathetic block

Unilateral lumbar sympathetic blockade using chirocaine

Group Type ACTIVE_COMPARATOR

lumbar sympathetic block

Intervention Type PROCEDURE

unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy

contralateral side

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lumbar sympathetic block

unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy

Intervention Type PROCEDURE

Other Intervention Names

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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)

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Locations

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Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Soo Young Park, MD

Role: primary

82-2-2072-0881

Other Identifiers

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H-0906-010-282

Identifier Type: OTHER

Identifier Source: secondary_id

Seoul National Univ Hospital

Identifier Type: -

Identifier Source: org_study_id

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