Clinical Trial: Horner's SD After Thoracic Epidural Block

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

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

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 Summary:

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.


Sponsor: Soonchunhyang University Hospital

Current Primary Outcome: Number of Participants with Horner's syndrome [ Time Frame: 3 day after the operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants with back pain [ Time Frame: 3 day after the operation ]
  • Number of Participants with radiating symptoms [ Time Frame: 3 day after the operation ]
    segmental pain or paresthesia corresponded to a dermatome of epidural block spinal root
  • Number of Participants with numbness [ Time Frame: 3 day after the operation ]
  • Number of Participants with muscular weakness [ Time Frame: 3 day after the operation ]


Original Secondary Outcome: Same as current

Information By: Soonchunhyang University Hospital

Dates:
Date Received: April 24, 2014
Date Started: September 2010
Date Completion:
Last Updated: May 1, 2014
Last Verified: May 2014