Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

Complex Regional Pain Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01134289
• Other study ID #: Seoul National Univ Hospital
• Secondary ID: H-0906-010-282
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2010
• Last updated: June 4, 2010
• Start date: September 2009

Study information

• Verified date: June 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of sympathetic block	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	Yes
Secondary	skin temperature changes	foot temperature change from baseline	1 minute at intervals during procedure	Yes
Secondary	electrocardiogram	heart rate variability measurement	1 minute at intervals from baseline through end of procedure	Yes