Horner's SyndromeNCT02130739
Horner's SD After Thoracic Epidural Block
An observational study of Horner's Syndrome, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Horner's Syndrome
- What is being tested?
- thoracic epidural anesthesia, mastectomy and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Apr 2014
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients, who scheduled for mastectomy with/without breast reconstruction
Who may be able to join
- Patients, who scheduled for mastectomy with/without breast reconstruction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy
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.
Read the 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
- Horner's Syndrome
- Being tested
- thoracic epidural anesthesia, mastectomy, Ropivacaine, Propofol, Fentanyl
- Keywords
- Anesthesia, Epidural, Thoracic Nerves, Horner syndrome
- Medical subject headings
- Horner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural anesthesiaProcedure or surgery
thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
mastectomyProcedure or surgery
mastectomy with/without breast reconstruction
RopivacaineDrug
Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
PropofolDrug
Thoracic epidural anesthesia performed followed by sedation consisting of propofol
FentanylDrug
thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural anesthesia | thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy Receives: Procedure: thoracic epidural anesthesia; Procedure: mastectomy; Drug: Ropivacaine; Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Horner's syndrome
Measured: 3 day after the operation
Secondary outcomes (4)
Number of Participants with back pain
Measured: 3 day after the operation
Number of Participants with radiating symptoms
segmental pain or paresthesia corresponded to a dermatome of epidural block spinal root
Measured: 3 day after the operation
Number of Participants with numbness
Measured: 3 day after the operation
Number of Participants with muscular weakness
Measured: 3 day after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Horner's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Young Park, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130739
- Sponsor's protocol ID
- HS-Tepi
- Status last verified
- May 2014
- First submitted
- 24 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25560203
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy
- ClinicalTrials.gov ID
- NCT02130739
- Acronym / sponsor ID
- HS-Tepi
- Conditions
- Horner's Syndrome
- Keywords
- Anesthesia, Epidural, Thoracic Nerves, Horner syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural anesthesia | – | Procedure: thoracic epidural anesthesia, Procedure: mastectomy, Drug: Ropivacaine, Drug: Propofol, Drug: Fentanylthoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, who scheduled for mastectomy with/without breast reconstruction
Key inclusion criteria (1 listed)
- Patients, who scheduled for mastectomy with/without breast reconstruction
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic epidural anesthesiathoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy | Procedure or surgery | thoracic epidural anesthesia |
| mastectomymastectomy with/without breast reconstruction | Procedure or surgery | thoracic epidural anesthesia |
| RopivacaineThoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine | Drug | thoracic epidural anesthesia |
| PropofolThoracic epidural anesthesia performed followed by sedation consisting of propofol | Drug | thoracic epidural anesthesia |
| Fentanylthoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h. | Drug | thoracic epidural anesthesia |
Primary outcome
Number of Participants with Horner's syndrome
Time frame: 3 day after the operation
4 secondary outcomes
Number of Participants with back pain
Time frame: 3 day after the operation
Number of Participants with radiating symptoms
Time frame: 3 day after the operation
Number of Participants with numbness
Time frame: 3 day after the operation
Number of Participants with muscular weakness
Time frame: 3 day after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Derived from this study: PubMed 25560203Park 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Horner's Syndrome, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Horner's syndrome (time frame: 3 day after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.