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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. completion date
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


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
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