Trials / Completed
CompletedNCT02130739
Horner's SD After Thoracic Epidural Block
Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (actual)
- Sponsor
- Soonchunhyang University Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-12-01
- Completion
- 2014-04-01
- First posted
- 2014-05-05
- Last updated
- 2014-05-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02130739. Inclusion in this directory is not an endorsement.