Shoulder SurgeryNCT02125994
Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System
A study testing Interscalene nerve block in people with Shoulder Surgery and Interscalene Nerve Block, run by Larissa University Hospital at 1 site in Greece.
Trial summary
It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Surgery, Interscalene Nerve Block, Ropivacaine
- What is being tested?
- Interscalene nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective shoulder surgery
- Age 18- 80 years old
- ASA I - IV
- Beach chair position
Who cannot join
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurological deficit on the side to be operated
- Allergy to local anesthetics
- Psychiatric disorders
- Patient's refusal
- Problems with patient communication
- Failure of the interscalene block
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Private Clinic of Larissa "Asklipeiio"
Larissa, Larissa
Marina Simaioforidou, Medicine, 00306972202573, msimaiof@gmail.com
About this study
Official title: Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position
It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.
The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.
- Conditions
- Shoulder Surgery, Interscalene Nerve Block, Ropivacaine
- Being tested
- Interscalene nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene nerve blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 0.5% | Active comparator | Ultrasound guided Intercalene nerve block with ropivacaine 0.5 % Receives: Procedure: Interscalene nerve block |
| Ropivacaine 0.375 % | Active comparator | Ultrasound guided Intercalene nerve block with ropivacaine 0.375 % Receives: Procedure: Interscalene nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure fluctuations
Measured: Completion of the surgery
Secondary outcomes (1)
Heart rate fluctuations
Measured: Completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- 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, Study director, Private Clinic of Larissa "Asklipeiio"Metaxia Bareka, Medicine, Principal investigator, University Hospital of LarisaGeorge Basdekis, Medicine, Study chair, Private Clinic of Larissa "Asklipeiio"Konstantinos Bargiotas, Medicine, Study chair, Larissa University HospitalSokrates Varitimidis, Medicine, Study chair, Larissa University HospitalAristeidis Zibis, Medicine, Study chair, Private Clinic of Larissa "Asklipeiio"Konstantinos Alexiou, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125994
- Sponsor's protocol ID
- Shoulder 0.5 vs 0.375
- Status last verified
- Apr 2014
- First submitted
- 27 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position
- ClinicalTrials.gov ID
- NCT02125994
- Acronym / sponsor ID
- Shoulder 0.5 vs 0.375
- Conditions
- Shoulder Surgery, Interscalene Nerve Block, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Apr 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.
It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.
The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 0.5% | Active comparator | Procedure: Interscalene nerve blockUltrasound guided Intercalene nerve block with ropivacaine 0.5 % |
| Ropivacaine 0.375 % | Active comparator | Procedure: Interscalene nerve blockUltrasound guided Intercalene nerve block with ropivacaine 0.375 % |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective shoulder surgery
- Age 18- 80 years old
- ASA I - IV
- Beach chair position
Key exclusion criteria (8 listed)
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurological deficit on the side to be operated
- Allergy to local anesthetics
- Psychiatric disorders
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 |
|---|---|---|
| Interscalene nerve block | Procedure or surgery | Ropivacaine 0.375 %, Ropivacaine 0.5% |
Primary outcome
Blood pressure fluctuations
Time frame: Completion of the surgery
1 secondary outcome
Heart rate fluctuations
Time frame: Completion of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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 study director
Private Clinic of Larissa "Asklipeiio"
Metaxia Bareka, Medicine principal investigator
University Hospital of Larisa
George Basdekis, Medicine study chair
Private Clinic of Larissa "Asklipeiio"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene nerve block in people with Shoulder Surgery and Interscalene Nerve 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 4 inclusion and 8 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 29 Apr 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 (0000306972202573, msimaiof@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure fluctuations (time frame: Completion of the surgery). 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 29 Apr 2014.