Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)
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ClinicalTrials.gov Identifier: NCT01134289 |
Recruitment Status : Unknown
Verified June 2010 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : May 31, 2010
Last Update Posted : June 7, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
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Complex Regional Pain Syndrome | Procedure: lumbar sympathetic block | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | February 2010 |

Arm | Intervention/treatment |
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Active Comparator: lumbar sympathetic block
Unilateral lumbar sympathetic blockade using chirocaine
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Procedure: lumbar sympathetic block
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
Other Names:
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No Intervention: contralateral side |
- Index of sympathetic block [ Time Frame: 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
- skin temperature changes [ Time Frame: 1 minute at intervals during procedure ]foot temperature change from baseline
- electrocardiogram [ Time Frame: 1 minute at intervals from baseline through end of procedure ]heart rate variability measurement

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Ages Eligible for Study: | 19 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134289
Korea, Republic of | |
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110744 | |
Contact: Soo Young Park, MD 82-2-2072-0881 soo02@snu.ac.kr |
Responsible Party: | Clinical Research Institute, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01134289 |
Other Study ID Numbers: |
Seoul National Univ Hospital H-0906-010-282 ( Other Identifier: SeoulNUH ) |
First Posted: | May 31, 2010 Key Record Dates |
Last Update Posted: | June 7, 2010 |
Last Verified: | June 2010 |
complex regional pain syndrome lumbar sympathetic blockade photoplethysmography diagnostic lumbar sympathetic blockade |
Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Syndrome Disease Pathologic Processes Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
Bupivacaine Levobupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |