Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

Phase 3

• Conditions: Complex Regional Pain Syndrome
• Interventions: Procedure: lumbar sympathetic block

• Registration Number: NCT01134289
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-02
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-04
• Last Update Posted: 2010-06-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lumbar sympathetic block	lumbar sympathetic block	Unilateral lumbar sympathetic blockade using chirocaine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of