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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01134289
Acronym
park001
Enrollment
25
Registered
2010-05-31
Start date
2009-09-30
Completion date
Unknown
Last updated
2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome

Keywords

complex regional pain syndrome, lumbar sympathetic blockade, photoplethysmography, diagnostic lumbar sympathetic blockade

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.

Interventions

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Index of sympathetic block1 minute at intervals from baseline through end of procedurechange 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

MeasureTime frameDescription
skin temperature changes1 minute at intervals during procedurefoot temperature change from baseline
electrocardiogram1 minute at intervals from baseline through end of procedureheart rate variability measurement

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026