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Horner's SD After Thoracic Epidural Block

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ClinicalTrials.gov Identifier: NCT02130739
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Sun Young Park, Soonchunhyang University Hospital

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.

Condition or disease Intervention/treatment
Horner's Syndrome Procedure: thoracic epidural anesthesia Procedure: mastectomy Drug: Ropivacaine Drug: Propofol Drug: Fentanyl

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Group/Cohort Intervention/treatment
thoracic epidural anesthesia
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
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.




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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, who scheduled for mastectomy with/without breast reconstruction
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130739


Locations
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Korea, Republic of
Soonchunhyang University Seoul Hospital
Seoul, Korea, Republic of, 140-743
Sponsors and Collaborators
Soonchunhyang University Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun Young Park, MD, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02130739    
Other Study ID Numbers: HS-Tepi
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Keywords provided by Sun Young Park, Soonchunhyang University Hospital:
Anesthesia
Epidural
Thoracic Nerves
Horner syndrome
Additional relevant MeSH terms:
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Horner Syndrome
Syndrome
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Miosis
Pupil Disorders
Neurologic Manifestations
Eye Diseases
Fentanyl
Propofol
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Local