Shoulder SurgeryNCT01755780
Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position
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, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Shoulder Surgery, Beach Chair Position, Interscalene Block
- What is being tested?
- Left interscalene block and Right interscalene block
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2012to Jul 2015
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for elective shoulder surgery
Who may be able to join
- elective shoulder surgery
- Age 50- 80 years old
- ASA II - IV
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
Larissa University Hospital
Larissa, Thessally, 41110
George Vretzakis, Medicine, 00302413502952, gvretzakis@yahoo.com
About this study
Official title: The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position
The Left interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position
- Conditions
- Shoulder Surgery, Beach Chair Position, Interscalene Block, Hypotension, Bradycardia, Autonomic Nervous System
- Being tested
- Left interscalene block, Right interscalene block
- Medical subject headings
- Hypotension, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left interscalene blockOther
Right interscalene blockOther
| Study group | Role | What they receive |
|---|---|---|
| Left interscalene block | Left interscalene block on hypotension and bradycardia during beach chair positioning Receives: Other: Left interscalene block | |
| Right interscalene block | Right interscalene block on hypotension and bradycardia during beach chair positioning Receives: Other: Right interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interscalene block and beach chair positioning
Effect of interscalene block on hypotension and bradycardia during beach chair positioning
Measured: Intraoperatively
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 2012
- Primary completionJan 2015 (estimated)
- Study completionJul 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
- Observational
- Observational model
- Case-control
- 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, Marina Simaioforidou, Larissa University Hospital
- Investigators
- Marina Simaioforidou, MD, Principal investigator, Larissa University HospitalGeorge Vretzakis, Medicine, Study director, Larissa University HospitalKaterina Tsiaka, Medicine, Study chair, Larissa University HospitalGeorge Basdekis, Medicine, Study chair, Larissa University HospitalAthanasios Drakos, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755780
- Sponsor's protocol ID
- Intrerscalene beach chair
- 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
- The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT01755780
- Acronym / sponsor ID
- Intrerscalene beach chair
- Conditions
- Shoulder Surgery, Beach Chair Position, Interscalene Block, Hypotension, Bradycardia, Autonomic Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (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 interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left interscalene block | – | Other: Left interscalene blockLeft interscalene block on hypotension and bradycardia during beach chair positioning |
| Right interscalene block | – | Other: Right interscalene blockRight interscalene block on hypotension and bradycardia during beach chair positioning |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for elective shoulder surgery
Key inclusion criteria (3 listed)
- elective shoulder surgery
- Age 50- 80 years old
- ASA II - IV
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 |
|---|---|---|
| Left interscalene block | Other | Left interscalene block |
| Right interscalene block | Other | Right interscalene block |
Primary outcome
Interscalene block and beach chair positioning
Time frame: Intraoperatively
Effect of interscalene block on hypotension and bradycardia during beach chair positioning
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.
Related trials for Shoulder Surgery
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
Driving After Shoulder Surgery
Shoulder
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, MD principal investigator
Larissa University Hospital
George Vretzakis, Medicine study director
Larissa University Hospital
Katerina 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 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 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 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?
Interscalene block and beach chair positioning (time frame: Intraoperatively). 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.