Study Results
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Basic Information
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COMPLETED
450 participants
OBSERVATIONAL
2010-09-30
2014-04-30
Brief Summary
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Detailed Description
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Six hundred thirty three Patients, who scheduled for mastectomy with/without breast reconstruction, were eligible for this prospective observational study from September 2010 to December 2013. Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine 15mL followed by sedation consisting of propofol without muscle relaxation. After the operation, thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h. At 1 hour, 2hour, 1 day, 2 day and 3 day after the operation, postoperative surveillance consisted of the occurrence of symptoms of Horner's syndrome (miosis, ptosis, and hyperemia) were performed by anesthesiologists.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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thoracic epidural anesthesia
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
thoracic epidural anesthesia
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
mastectomy
mastectomy with/without breast reconstruction
Ropivacaine
Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
Propofol
Thoracic epidural anesthesia performed followed by sedation consisting of propofol
Fentanyl
thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.
Interventions
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thoracic epidural anesthesia
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
mastectomy
mastectomy with/without breast reconstruction
Ropivacaine
Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
Propofol
Thoracic epidural anesthesia performed followed by sedation consisting of propofol
Fentanyl
thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Petechiae, or ecchymosis, or anatomic or neurologic abnormalities
* That is, significant scoliosis or kyphosis, radyculopathy or ptosis
* Unsuccessful catheter placement (impossible to insert a catheter at two vertebral levels)
* Unsuccessful epidural anesthesia (not checkable sensory block)
* Dural perforation or intravascular catheterization
20 Years
80 Years
FEMALE
No
Sponsors
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Soonchunhyang University Hospital
OTHER
Responsible Party
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Sun Young Park
MD
Locations
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Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Countries
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References
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Park SY, Chun HR, Kim MG, Lee SJ, Kim SH, Ok SY, Cho A. Transient Horner's syndrome following thoracic epidural anesthesia for mastectomy: a prospective observational study. Can J Anaesth. 2015 Mar;62(3):252-7. doi: 10.1007/s12630-014-0284-9. Epub 2015 Jan 6.
Other Identifiers
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HS-Tepi
Identifier Type: -
Identifier Source: org_study_id
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