Horner's SD After Thoracic Epidural Block

Horner's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130739
• Other study ID #: HS-Tepi
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: May 1, 2014
• Start date: September 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Horner Syndrome
• Horner's Syndrome

Intervention

Procedure:
• thoracic epidural anesthesia
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
• mastectomy
mastectomy with/without breast reconstruction

Drug:
• Ropivacaine
Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
• Propofol
Thoracic epidural anesthesia performed followed by sedation consisting of propofol
• Fentanyl
thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Horner's syndrome		3 day after the operation	Yes
Secondary	Number of Participants with back pain		3 day after the operation	Yes
Secondary	Number of Participants with radiating symptoms	segmental pain or paresthesia corresponded to a dermatome of epidural block spinal root	3 day after the operation	Yes
Secondary	Number of Participants with numbness		3 day after the operation	Yes
Secondary	Number of Participants with muscular weakness		3 day after the operation	Yes