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Horner's SD After Thoracic Epidural Block

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02130739
Enrollment
450
Registered
2014-05-05
Start date
2010-09-30
Completion date
2014-04-30
Last updated
2014-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horner's Syndrome

Keywords

Anesthesia, Epidural, Thoracic Nerves, Horner syndrome

Brief 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.

Interventions

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

PROCEDUREmastectomy

mastectomy with/without breast reconstruction

DRUGRopivacaine

Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine

DRUGPropofol

Thoracic epidural anesthesia performed followed by sedation consisting of propofol

DRUGFentanyl

thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.

Sponsors

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients, who scheduled for mastectomy with/without breast reconstruction

Exclusion criteria

* The patients who had more than one abnormal preoperative clotting parameter either clinical signs of potential bleeding disorders suggested by bruising * 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

Design outcomes

Primary

MeasureTime frame
Number of Participants with Horner's syndrome3 day after the operation

Secondary

MeasureTime frameDescription
Number of Participants with back pain3 day after the operation
Number of Participants with radiating symptoms3 day after the operationsegmental pain or paresthesia corresponded to a dermatome of epidural block spinal root
Number of Participants with numbness3 day after the operation
Number of Participants with muscular weakness3 day after the operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026