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Completed

NCT Number: NCT02130739

Horner's SD After Thoracic Epidural Block

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.

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Key information

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Soonchunhyang University Seoul Hospital

Seoul, 140-743, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thoracic epidural anesthesia

Procedure

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

mastectomy

Procedure

mastectomy with/without breast reconstruction

Ropivacaine

Drug

Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine

Propofol

Drug

Thoracic epidural anesthesia performed followed by sedation consisting of propofol

Fentanyl

Drug

thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.

Primary outcomes

  1. Number of Participants with Horner's syndrome

    Time frame: 3 day after the operation

Secondary outcomes

  1. Number of Participants with back pain

    Time frame: 3 day after the operation

  2. 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

  3. Number of Participants with numbness

    Time frame: 3 day after the operation

  4. Number of Participants with muscular weakness

    Time frame: 3 day after the operation

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 5, 2014
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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