Shoulder SurgeryNCT01185457
Effect of Interscalene Block on Heart Rate Variability (HRV)
An observational study of Shoulder Surgery and Beach Chair Position, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The Left interscalene block has 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 45 years
- Conditions the study is for
- Shoulder Surgery, Beach Chair Position, Interscalene Block
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2010to Sep 2012
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients for elective shoulder surgery
Who may be able to join
- elective shoulder surgery
- Age 20- 45 years old
- ASA I - II
Who cannot join
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurologic deficit in the arm that is going to be operated
- 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.
About this study
Official title: Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement
The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block
- Keywords
- Shoulder surgery, Beach chair position, Interscalene block, HRV, Autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left interscalene block | Left shoulder surgery under left interscalene block and HRV | |
| Right interscalene block | Right shoulder surgery under right interscalene block and HRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of interscalene block on Heart Rate Variability (HRV)
The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
Measured: 1 year
Secondary outcomes (2)
Interscalene block and beach chair positioning
Effect of interscalene block on hypotension during beach chair positioning
Measured: 2 years
Interscalene block and beach chair positioning
Effect of interscalene block on bradycardia during beach chair positioning
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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 crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni Chantzi, Larissa University Hospital
- Investigators
- Eleni Chantzi, Medicine, Principal investigator, Larissa University HospitalGeorge Vretzakis, Medicine, Study director, Larissa University HospitalMetaxia Bareka, Medicine, Study chair, Larissa University HospitalChristos Iatrou, Medicine, Study chair, Alexandroupoli University HospitalTheophilos Karachalios, Medicine, Study chair, Larissa University HospitalMarina Simaioforidou, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185457
- Sponsor's protocol ID
- HRVShoulder
- Status last verified
- Oct 2012
- First submitted
- 18 Aug 2010
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pomeranz B, Macaulay RJ, Caudill MA, Kutz I, Adam D, Gordon D, Kilborn KM, Barger AC, Shannon DC, Cohen RJ, et al. Assessment of autonomic function in humans by heart rate spectral analysis. Am J Physiol. 1985 Jan;248(1 Pt 2):H151-3. doi: 10.1152/ajpheart.1985.248.1.H151.
PubMed 3970172Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.
PubMed 2874900Muzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993
Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. doi: 10.1161/01.cir.84.2.482.
PubMed 1860193RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. doi: 10.1161/01.res.4.4.470. No abstract available.
PubMed 13330193Rogers MC, Battit G, McPeek B, Todd D. Lateralization of sympathetic control of the human sinus node: ECG changes of stellate ganglion block. Anesthesiology. 1978 Feb;48(2):139-41. doi: 10.1097/00000542-197802000-00009. No abstract available.
PubMed 655444Schwartz PJ, Locati EH, Moss AJ, Crampton RS, Trazzi R, Ruberti U. Left cardiac sympathetic denervation in the therapy of congenital long QT syndrome. A worldwide report. Circulation. 1991 Aug;84(2):503-11. doi: 10.1161/01.cir.84.2.503.
PubMed 1860195
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement
- ClinicalTrials.gov ID
- NCT01185457
- Acronym / sponsor ID
- HRVShoulder
- Keywords
- Shoulder surgery, Beach chair position, Interscalene block, HRV, Autonomic nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Aug 2010 (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 interscalene block has 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 crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left interscalene block | – | –Left shoulder surgery under left interscalene block and HRV |
| Right interscalene block | – | –Right shoulder surgery under right interscalene block and HRV |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients for elective shoulder surgery
Key inclusion criteria (3 listed)
- elective shoulder surgery
- Age 20- 45 years old
- ASA I - II
Key exclusion criteria (15 listed)
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurologic deficit in the arm that is going to be operated
- 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.
Primary outcome
Effect of interscalene block on Heart Rate Variability (HRV)
Time frame: 1 year
The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
2 secondary outcomes
Interscalene block and beach chair positioning
Time frame: 2 years
Interscalene block and beach chair positioning
Time frame: 2 years
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 29 Oct 2012.
- Background: PubMed 3970172Pomeranz B, Macaulay RJ, Caudill MA, Kutz I, Adam D, Gordon D, Kilborn KM, Barger AC, Shannon DC, Cohen RJ, et al. Assessment of autonomic function in humans by heart rate spectral analysis. Am J Physiol. 1985 Jan;248(1 Pt 2):H151-3. doi: 10.1152/ajpheart.1985.248.1.H151.
- Background: PubMed 2874900Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.
- BackgroundMuzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993
- Background: PubMed 1860193Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. doi: 10.1161/01.cir.84.2.482.
- Background: PubMed 13330193RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. doi: 10.1161/01.res.4.4.470. No abstract available.
- Background: PubMed 655444Rogers MC, Battit G, McPeek B, Todd D. Lateralization of sympathetic control of the human sinus node: ECG changes of stellate ganglion block. Anesthesiology. 1978 Feb;48(2):139-41. doi: 10.1097/00000542-197802000-00009. No abstract available.
- Background: PubMed 1860195Schwartz PJ, Locati EH, Moss AJ, Crampton RS, Trazzi R, Ruberti U. Left cardiac sympathetic denervation in the therapy of congenital long QT syndrome. A worldwide report. Circulation. 1991 Aug;84(2):503-11. doi: 10.1161/01.cir.84.2.503.
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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.
Eleni Chantzi, Medicine principal investigator
Larissa University Hospital
George Vretzakis, Medicine study director
Larissa University Hospital
Metaxia Bareka, 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 Shoulder Surgery and Beach Chair Position, 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: finished, as of the sponsor's last update on 29 Oct 2012. 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?
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?
Effect of interscalene block on Heart Rate Variability (HRV) (time frame: 1 year). 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 NCT01185457, which also lists 7 linked publications.
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 29 Oct 2012.