Clinical trial NCT02130739: Horner's SD After Thoracic Epidural Block
Official title: Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Horner's Syndrome
Keywords: Anesthesia
Epidural
Thoracic Nerves
Horner syndrome
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 450
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who scheduled for mastectomy with/without breast reconstruction

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Horner's syndrome
timeFrame: 3 day after the operation
Secondary outcomes:
measure: Number of Participants with back pain
timeFrame: 3 day after the operation
measure: Number of Participants with radiating symptoms
timeFrame: 3 day after the operation
measure: Number of Participants with numbness
timeFrame: 3 day after the operation
measure: Number of Participants with muscular weakness
timeFrame: 3 day after the operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
Study officials:
References:
citation: 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.