Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Seoul National University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01134289
First received: May 19, 2010
Last updated: June 4, 2010
Last verified: June 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Complex Regional Pain Syndrome |
Procedure: lumbar sympathetic block |
Phase 3 |
| Study Type: | Interventional |
| 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 |
| Official Title: | An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Index of sympathetic block [ Time Frame: 1 minute at intervals from baseline through end of procedure ] [ Designated as safety issue: Yes ]
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:
- skin temperature changes [ Time Frame: 1 minute at intervals during procedure ] [ Designated as safety issue: Yes ]foot temperature change from baseline
- electrocardiogram [ Time Frame: 1 minute at intervals from baseline through end of procedure ] [ Designated as safety issue: Yes ]heart rate variability measurement
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: lumbar sympathetic block
Unilateral lumbar sympathetic blockade using chirocaine
|
Procedure: lumbar sympathetic block
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
Other Names:
|
| No Intervention: contralateral side |
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01134289
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134289
Locations
| 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 | |
Sponsors and Collaborators
Seoul National University Hospital
More Information
| Responsible Party: | Clinical Research Institute, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01134289 History of Changes |
| Other Study ID Numbers: | Seoul National Univ Hospital H-0906-010-282 |
| Study First Received: | May 19, 2010 |
| Last Updated: | June 4, 2010 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
complex regional pain syndrome lumbar sympathetic blockade photoplethysmography diagnostic lumbar sympathetic blockade |
Additional relevant MeSH terms:
|
Syndrome Somatoform Disorders Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Disease Pathologic Processes Mental Disorders Autonomic Nervous System Diseases Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Levobupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 23, 2016