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CompletedNCT02130739

Horner's SD After Thoracic Epidural Block

Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy

Status
Completed
Phase
Study type
Observational
Enrollment
450 (actual)
Sponsor
Soonchunhyang University Hospital · Academic / Other
Sex
Female
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was 1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.

Detailed description

Transient Horner's syndrome has been recognized rare complication of epidural anesthesia and the incidence is not exactly well-known in thoracic epidural anesthesia. Therefore, this study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy. 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

Interventions

TypeNameDescription
PROCEDUREthoracic epidural anesthesiathoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
PROCEDUREmastectomymastectomy with/without breast reconstruction
DRUGRopivacaineThoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
DRUGPropofolThoracic epidural anesthesia performed followed by sedation consisting of propofol
DRUGFentanylthoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.

Timeline

Start date
2010-09-01
Primary completion
2013-12-01
Completion
2014-04-01
First posted
2014-05-05
Last updated
2014-05-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02130739. Inclusion in this directory is not an endorsement.