Horner's SD After Thoracic Epidural Block

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

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.

Study Overview

• Status: Completed
• Conditions: Horner's Syndrome
• Intervention / Treatment: Procedure: thoracic epidural anesthesia; Procedure: mastectomy; Drug: Ropivacaine; Drug: Propofol; Drug: Fentanyl

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.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 140-743
    • SoonChunHyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients, who scheduled for mastectomy with/without breast reconstruction

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

thoracic epidural anesthesia; thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Epidural; Anesthesia; Thoracic Nerves; Horner syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease; Autonomic Nervous System Diseases; Miosis; Pupil Disorders; Syndrome; Horner Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Propofol; Ropivacaine
• Other Study ID Numbers: HS-Tepi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No