Anesthesia, LocalNCT05968105
Changes in Vessels After Peripheral Block
An observational study of Anesthesia, Local and Vena Cava Syndrome (Inferior) (Superior), run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood circulation is kept in the central area. It causes arterial vasodilation and hemodynamic variability by increasing the blood volume of the extremity due to the sympathectomy occurring after the block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Local, Vena Cava Syndrome (Inferior) (Superior), Fluid Loss
- What is being tested?
- Lateral Sagittal Infraclavicular Block, Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50% and Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2023to 3 Dec 2023
- How long will I take part?
- 3 Months
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Block differences will be observed when patients who undergo routine hand surgery operations under the lateral sagittal infraclavicular block are classified according to the Vena Cava Inferior - Collapsibility Index.
Who may be able to join
- Hand and Wrist elective surgery
- Infraclavicular block will be applied
- American Society of Anesthesiologists (ASA) physical condition I-II
- Patients aged 18-65 years
Who cannot join
- Contraindication for central or peripheral blocks
- Cognitive dysfunction
- History of chronic opioid use
- severe organ dysfunction
- Allergy to any drug used in the study
- Body mass index (BMI) ≥30
- Infection in the area to be treated
- Refusal to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lateral Sagittal Infraclavicular Block According to Vena Cava Inferior Collapsibility Index (VCI-CI): An Observational Study
In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood circulation is kept in the central area. It causes arterial vasodilation and hemodynamic variability by increasing the blood volume of the extremity due to the sympathectomy occurring after the block. When the investigators classify patients according to VCI-CI, it will be questioned whether there is a difference between patients' block quality and hemodynamic variability.
Read the detailed description
VCI-CI helps us to have an idea about the amount of fluid in patients according to the vena cava Inferior (VCI) diameter and the diameter between the inspiring and expiration. Low arterial diameter and high inspiratory and expiratory variability indicate that the patient's fluid volume may be lower.
In the measurement of VCI diameter, VCI has visualized in the craniocaudal plane thanks to the transverse ultrasound probe. Changes in VCI diameter are observed depending on the negative pressure in the thoracic area during inspiration and expiration. When the difference between this rate of change is greater than 50%, it indicates that the patient has a fluid deficit. The fact that the VCI diameter is also below 1.5 cm indicates that this amount of fluid requirement is more serious. In this study, the investigators will question whether there is a difference between patients' block quality and hemodynamic variability when they classify patients according to VCI-CI.
- Conditions
- Anesthesia, Local, Vena Cava Syndrome (Inferior) (Superior), Fluid Loss, Postoperative Pain
- Being tested
- Lateral Sagittal Infraclavicular Block, Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%, Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%
- Keywords
- Vena Cava Inferior Collapsibility Index, Lateral Sagittal Infraclavicular Block, VCI-CI
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Sagittal Infraclavicular BlockProcedure or surgery
Patients will be in the supine position and after aseptic conditions are provided, the axillary artery of the patient will be visualized in the craniocaudal plane, in the infraclavicular region and in the lateral sagittal position with the help of an 8-12 mHz linear probe. After the brachial plexus cords around the axillary artery are identified, a local anesthetic mixture will be applied in-plane between the posterior cord and the artery. During the block, patients will routinely be given a mixture of 0.25% bupivacaine + 0.5% lidocaine 0.5 mL/kg.
Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%Procedure or surgery
While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.
Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%Diagnostic test
While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Inferior vena cava diameter <1.5 cm and VCI-CI > 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI) Receives: Procedure: Lateral Sagittal Infraclavicular Block; Diagnostic Test: Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50% | |
| Group 2 | Inferior vena cava diameter >1.5 cm and VCI-CI < 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI) Receives: Procedure: Lateral Sagittal Infraclavicular Block; Procedure: Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler flow change from baseline to postoperative period
Before the block, with the help of 8-12 mHz linear probe, the axillary artery of the patients will be determined in the lateral sagittal plane and their diameters at the time of systole and diastole will be determined. After the arterial diameters are determined, the probe will be positioned to view the artery in a linear line with 90 degree rotation. After imaging the axillary artery in the long axis, confirming it with 5 sequential flows in B-mode Doppler, PSV (Peak systolic velocity), EDV (End diastolic velocity), mV (mean velocity), RI index and PI index probe angulation at 30-60 degree angle, ultrasound will be measured automatically. After the block, the sensory and motor block times of the patients were determined and these times were recorded.
Measured: Perioperative period
Secondary outcomes (3)
VAS (Visual Analog Scala) score
The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.
Measured: Postoperative 24th hour
Analgesic consumption
he value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals
Measured: Postoperative 24th hour
Postoperative nausea and vomiting
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start2 Aug 2023
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
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 Anesthesia, LocalStudies 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
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ergün Mendeş, Başakşehir Çam & Sakura City Hospital
- Investigators
- Ergun Mendes, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968105
- Sponsor's protocol ID
- e.mendes - 3
- Other IDs
- KAEK/2023.06.260
- Status last verified
- Dec 2023
- First submitted
- 13 Jul 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
Zhang H, Yuan H, Yu H, Zhang Y, Feng S. Correlation between pleth variability index and ultrasonic inferior vena cava-collapsibility index in parturients with twin pregnancies undergoing cesarean section under spinal anesthesia. Eur J Med Res. 2022 Aug 6;27(1):139. doi: 10.1186/s40001-022-00771-3.
PubMed 35933431
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lateral Sagittal Infraclavicular Block According to Vena Cava Inferior Collapsibility Index (VCI-CI): An Observational Study
- ClinicalTrials.gov ID
- NCT05968105
- Acronym / sponsor ID
- e.mendes - 3
- Conditions
- Anesthesia, Local, Vena Cava Syndrome (Inferior) (Superior), Fluid Loss, Postoperative Pain
- Keywords
- Vena Cava Inferior Collapsibility Index, Lateral Sagittal Infraclavicular Block, VCI-CI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- 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.
In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood circulation is kept in the central area. It causes arterial vasodilation and hemodynamic variability by increasing the blood volume of the extremity due to the sympathectomy occurring after the block. When the investigators classify patients according to VCI-CI, it will be questioned whether there is a difference between patients' block quality and hemodynamic variability.
Detailed description
VCI-CI helps us to have an idea about the amount of fluid in patients according to the vena cava Inferior (VCI) diameter and the diameter between the inspiring and expiration. Low arterial diameter and high inspiratory and expiratory variability indicate that the patient's fluid volume may be lower.
In the measurement of VCI diameter, VCI has visualized in the craniocaudal plane thanks to the transverse ultrasound probe. Changes in VCI diameter are observed depending on the negative pressure in the thoracic area during inspiration and expiration. When the difference between this rate of change is greater than 50%, it indicates that the patient has a fluid deficit. The fact that the VCI diameter is also below 1.5 cm indicates that this amount of fluid requirement is more serious. In this study, the investigators will question whether there is a difference between patients' block quality and hemodynamic variability when they classify patients according to VCI-CI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Lateral Sagittal Infraclavicular Block, Diagnostic Test: Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%Inferior vena cava diameter <1.5 cm and VCI-CI > 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI) |
| Group 2 | – | Procedure: Lateral Sagittal Infraclavicular Block, Procedure: Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%Inferior vena cava diameter >1.5 cm and VCI-CI < 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Block differences will be observed when patients who undergo routine hand surgery operations under the lateral sagittal infraclavicular block are classified according to the Vena Cava Inferior - Collapsibility Index.
Key inclusion criteria (4 listed)
- Hand and Wrist elective surgery
- Infraclavicular block will be applied
- American Society of Anesthesiologists (ASA) physical condition I-II
- Patients aged 18-65 years
Key exclusion criteria (8 listed)
- Contraindication for central or peripheral blocks
- Cognitive dysfunction
- History of chronic opioid use
- severe organ dysfunction
- Allergy to any drug used in the study
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 |
|---|---|---|
| Lateral Sagittal Infraclavicular BlockPatients will be in the supine position and after aseptic conditions are provided, the axillary artery of the patient will be visualized in the craniocaudal plane, in the infraclavicular region and in the lateral sagittal position with the help of an 8-12 mHz linear probe. After the brachial plexus cords around the axillary artery are identified, a local anesthetic mixture will be applied in-plane between the posterior cord and the artery. During the block, patients will routinely be given a mixture of 0.25% bupivacaine + 0.5% lidocaine 0.5 mL/kg. | Procedure or surgery | Group 1, Group 2 |
| Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated. | Procedure or surgery | Group 2 |
| Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated. | Diagnostic test | Group 1 |
Primary outcome
Doppler flow change from baseline to postoperative period
Time frame: Perioperative period
Before the block, with the help of 8-12 mHz linear probe, the axillary artery of the patients will be determined in the lateral sagittal plane and their diameters at the time of systole and diastole will be determined. After the arterial diameters are determined, the probe will be positioned to view the artery in a linear line with 90 degree rotation. After imaging the axillary artery in the long axis, confirming it with 5 sequential flows in B-mode Doppler, PSV (Peak systolic velocity), EDV (End diastolic velocity), mV (mean velocity), RI index and PI index probe angulation at 30-60 degree angle, ultrasound will be measured automatically. After the block, the sensory and motor block times of the patients were determined and these times were recorded.
3 secondary outcomes
VAS (Visual Analog Scala) score
Time frame: Postoperative 24th hour
Analgesic consumption
Time frame: Postoperative 24th hour
Postoperative nausea and vomiting
Time frame: Postoperative 24th hour
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 8 Dec 2023.
- Background: PubMed 35933431Zhang H, Yuan H, Yu H, Zhang Y, Feng S. Correlation between pleth variability index and ultrasonic inferior vena cava-collapsibility index in parturients with twin pregnancies undergoing cesarean section under spinal anesthesia. Eur J Med Res. 2022 Aug 6;27(1):139. doi: 10.1186/s40001-022-00771-3.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
Ergun Mendes principal investigator
Başakşehir Çam & Sakura City 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 Anesthesia, Local and Vena Cava Syndrome (Inferior) (Superior), run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 8 Dec 2023. 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 Turkey (Türkiye). 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?
Doppler flow change from baseline to postoperative period (time frame: Perioperative period). 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 NCT05968105, 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 8 Dec 2023.