NCT02130739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

April 24, 2014

Last Update Submit

May 1, 2014

Conditions

Horner's Syndrome

Keywords

AnesthesiaEpiduralThoracic NervesHorner syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Horner's syndrome

    3 day after the operation

Secondary Outcomes (4)

  • Number of Participants with back pain

    3 day after the operation

  • Number of Participants with radiating symptoms

    3 day after the operation

  • Number of Participants with numbness

    3 day after the operation

  • Number of Participants with muscular weakness

    3 day after the operation

Study Arms (1)

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

Procedure: thoracic epidural anesthesiaProcedure: mastectomyDrug: RopivacaineDrug: PropofolDrug: Fentanyl

Interventions

thoracic epidural anesthesiaPROCEDURE

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

thoracic epidural anesthesia
mastectomyPROCEDURE

mastectomy with/without breast reconstruction

thoracic epidural anesthesia
RopivacaineDRUG

Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine

thoracic epidural anesthesia
PropofolDRUG

Thoracic epidural anesthesia performed followed by sedation consisting of propofol

thoracic epidural anesthesia
FentanylDRUG

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

thoracic epidural anesthesia

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients, who scheduled for mastectomy with/without breast reconstruction

You may qualify if:

  • Patients, who scheduled for mastectomy with/without breast reconstruction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Seoul Hospital

Seoul, 140-743, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25560203DERIVED

MeSH Terms

Conditions

Horner Syndrome

Interventions

MastectomyRopivacainePropofolFentanyl

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesCavernous Sinus SyndromesBrain DiseasesCentral Nervous System DiseasesMiosisPupil DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2014

First Posted

May 5, 2014

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

KR(1)