Horner's SD After Thoracic Epidural Block

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Horner's Syndrome

Intervention / Treatment
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* Procedure: thoracic epidural anesthesia
* Procedure: mastectomy
* Drug: Ropivacaine
* Drug: Propofol
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| thoracic epidural anesthesia<br>thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy | Procedure: thoracic epidural anesthesia<br>* thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy<br>Procedure: mastectomy<br>* mastectomy with/without breast reconstruction<br>Drug: Ropivacaine<br>* Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine<br>Drug: Propofol<br>* Thoracic epidural anesthesia performed followed by sedation consisting of propofol<br>Drug: Fentanyl<br>* thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Horner's syndrome |  | 3 day after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with back pain |  | 3 day after the operation | 
| Number of Participants with radiating symptoms | segmental pain or paresthesia corresponded to a dermatome of epidural block spinal root | 3 day after the operation | 
| Number of Participants with numbness |  | 3 day after the operation | 
| Number of Participants with muscular weakness |  | 3 day after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Epidural, Thoracic Nerves, Horner syndrome