Breast SurgeryNCT01755910
Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)
An observational study of Breast Surgery and Thoracic Paravertebral Block, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Surgery, Thoracic Paravertebral Block, HRV
- What is being tested?
- Left thoracic paravertebral block and Right thoracic paravertebral block
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2014to Jul 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients for elective breast surgery
Who may be able to join
- Elective breast surgery
- Age 20 - 65 years
- ASA I - II
Who cannot join
- Coagulopathy disorders
- Infection at the puncture site for the thoracic paravertebral block
- Severe kyphoscoliosis
- Allergy to local anesthetics
- BMI > 35
- Psychiatric disorders
Show all 15Show fewer
- Patient's refusal
- Problems with patient communication
- Arrythmia
- Ischaemic heart disease
- Diabetes mellitus
- Thyroid function disorders
- Patients with conduction disorders on the ECG
- Electrolyte disorders (K+, Na+, Ca++)
- Patients on medication that affect the ECG
Trial locations and contacts
1 site in 1 country.
Greece1 site
Larissa University Hospital
Larissa, Thessally, 41110
George Vretzakis, Medicine, 00302413502952 ext. 2952, gvretzakis@yahoo.com
About this study
Official title: Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)
The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block
- Being tested
- Left thoracic paravertebral block, Right thoracic paravertebral block
- Keywords
- Breast Surgery, Thoracic Paravertebral Block, HRV, Autonomic Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left thoracic paravertebral blockOther
Right thoracic paravertebral blockOther
| Study group | Role | What they receive |
|---|---|---|
| Left thoaracic paravertebral block | Surgery in the left breast under left thoracic paravertebral block and HRV Receives: Other: Left thoracic paravertebral block | |
| Right thoracic paravertebral block and HRV | Surgery in the right breast under right thoracic paravertebral block and HRV Receives: Other: Right thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of thoracic paravertebral block on Heart Rate Variability (HRV)
The Left thoracic paravertebral block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
Measured: 30 min after the application of the thoracic paravertebral block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Simaioforidou, Larissa University Hospital
- Investigators
- Marina Simaioforidou, Medicine, Principal investigator, Larissa University HospitalGeorge Vretzakis, Medicine, Study director, Larissa University HospitalAikaterini Tsiaka, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755910
- Sponsor's protocol ID
- HRV Thoracic paravertebral
- Status last verified
- Jul 2014
- First submitted
- 19 Dec 2012
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)
- ClinicalTrials.gov ID
- NCT01755910
- Acronym / sponsor ID
- HRV Thoracic paravertebral
- Keywords
- Breast Surgery, Thoracic Paravertebral Block, HRV, Autonomic Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Dec 2012 (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.
The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left thoaracic paravertebral block | – | Other: Left thoracic paravertebral blockSurgery in the left breast under left thoracic paravertebral block and HRV |
| Right thoracic paravertebral block and HRV | – | Other: Right thoracic paravertebral blockSurgery in the right breast under right thoracic paravertebral block and HRV |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for elective breast surgery
Key inclusion criteria (3 listed)
- Elective breast surgery
- Age 20 - 65 years
- ASA I - II
Key exclusion criteria (15 listed)
- Coagulopathy disorders
- Infection at the puncture site for the thoracic paravertebral block
- Severe kyphoscoliosis
- Allergy to local anesthetics
- BMI > 35
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 |
|---|---|---|
| Left thoracic paravertebral block | Other | Left thoaracic paravertebral block |
| Right thoracic paravertebral block | Other | Right thoracic paravertebral block and HRV |
Primary outcome
Effect of thoracic paravertebral block on Heart Rate Variability (HRV)
Time frame: 30 min after the application of the thoracic paravertebral block
The Left thoracic paravertebral block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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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.
Marina Simaioforidou, Medicine principal investigator
Larissa University Hospital
George Vretzakis, Medicine study director
Larissa University Hospital
Aikaterini Tsiaka, Medicine study chair
Larissa University Hospital
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 Breast Surgery and Thoracic Paravertebral Block, run by Larissa University Hospital at 1 site in Greece.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 10 Jul 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Simaioforidou, Medicine (00306972202573, msimaiof@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of thoracic paravertebral block on Heart Rate Variability (HRV) (time frame: 30 min after the application of the thoracic paravertebral block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2014.