CClinicalTrials.gg
Status unknownNCT01134289park001Updated Jun 7, 2010

Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

A Phase 3 interventional study of lumbar sympathetic block in Complex Regional Pain Syndrome, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-06-07.

Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Complex Regional Pain Syndrome

Keywords

  • complex regional pain syndrome
  • lumbar sympathetic blockade
  • photoplethysmography
  • diagnostic lumbar sympathetic blockade
03

In context

Complex Regional Pain Syndromes

198 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.

This study's planned enrollment of 25 is below the median of 40 across 146 interventional studies indexed under Complex Regional Pain Syndromes.

Browse Complex Regional Pain Syndromes studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • Graded as ASA 3 or higher,
  • Below 18 or above 70 years of age, or
  • Had any other contraindication for regional anesthesia.
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    lumbar sympathetic block

    Unilateral lumbar sympathetic blockade using chirocaine

    Procedure: lumbar sympathetic block

  • No intervention
    contralateral side

Interventions

  • Procedurelumbar sympathetic block

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

    Also known as: 0.25% bupivacaine (Chirocaine, Abbott, Elverum, Norway), C-arm (OEC 9800 plus, GE Medical Systems, Salt Lake City, UT), Chiba needle (Cook Inc., Bloomington, IN)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 minute at intervals from baseline through end of procedure

Secondary outcomes

  1. skin temperature changes

    foot temperature change from baseline

    Time frame: 1 minute at intervals during procedure

  2. electrocardiogram

    heart rate variability measurement

    Time frame: 1 minute at intervals from baseline through end of procedure

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
    Seoul, 110744, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01134289
Lead sponsor
Seoul National University Hospital
First posted
May 31, 2010
Start date
Sep 2009
Primary completion
Feb 2010 (estimated)
Last update
Jun 7, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion