Brachial Plexus BlockNCT05434975
The Effect of Interscalene Block on Intracranial Pressure
A study testing Interscalene brachial plexus block in people with Brachial Plexus Block and Intracranial Pressure Increase, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to show the effects of interscalene brachial plexus (ISBP) block on intracranial pressure by measuring optic nerve sheath diameter (ONSD) and internal vein collapsibility index (IJV-CI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brachial Plexus Block, Intracranial Pressure Increase
- What is being tested?
- Interscalene brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2022to 15 Sep 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had elective humeral fracture and open rotator-cuff surgery,
- Patients aged 18-85 years,
- Patients have ASA I-II anesthesia risk according to the American Society of Anesthesiologists (ASA) risk classification,
- Patients that gave consent for participation in the study will be included.
Who cannot join
- Patients who do not give consent to the study,
- Patients with infection and open wounds in the area of skin puncture and eyelids,
- Patients have any history of intracranial pathology,
- Patients have nerve blockade contraindications such as coagulation disorder and antithrombotic-anticoagulant use,
- Patients have a history of allergy to one of the study drugs,
- Patients have a body mass index over 35 kg/m2,
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- Patients with contralateral pneumothorax,
- Patients with severe respiratory distress,
- Patients with uncontrolled hypertension,
- Patients with acute or chronic eye disease,
- Patients with previous eye surgery,
- Patients using a beta-blocker known to increase intraocular pressure,
- Patients using calcium channel blockers, statins and nitrates,
- Patients in need of intraoperative sedation,
- Patients who develope any complications (hoarseness, horner's syndrome, respiratory distress, local anesthetic toxicity) due to ISBP block will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas, 58000
Oğuz Gündoğdu, Assist. Prof, +905545945469, droguzgundogdu@gmail.com
About this study
Official title: Evaluation of the Effect of Interscalene Block on Intracranial Pressure by Sonographic Measurements of Optic Nerve Sheath Diameter and Internal Jugular Vein Collapsibility Index
The study aims to show the effects of interscalene brachial plexus (ISBP) block on intracranial pressure by measuring optic nerve sheath diameter (ONSD) and internal vein collapsibility index (IJV-CI).
Read the detailed description
40 is the targeted number of patients who are going to have humerus fracture or opened rotator-cuff surgery. Single shot-ISBP block with 25 ml local anesthetic will be performed as anesthetic approach for surgery to all participants. Intraoperative ONSD and IJV-CI measurements will be performed before the ISBP block, 20 minutes and 60 minutes after the block. Hypothesis; external drug-volume effect on internal jugular vein causes decreasing maximum diameter of internal jugular vein (Dmax), venous return from cranium to heart decreases, intracranial pressure can increase.
- Being tested
- Interscalene brachial plexus block
- Keywords
- interscalene brachial plexus block, intracranial pressure, optic nerve sheath diameter, internal jugular vein collapsibility index
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
For single shot-ISBP block, 15 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine, a total of 25 ml of local anesthetic, will be administered to all patients.
For the block procedure, an imaginary horizontal line drawn from the thyroid cartilage to the sternocleidomastoid (SCM) muscle will followed and the lateral of the SCM muscle will be cleaned with povidine iodine. At the C6 level to be blocked, the nerve roots will be detected by ultrasound. 25 ml of local anesthetic will be injected around the plexus roots with a 22 G 80 mm echogenic needle. The distribution of the local anesthetic applied to the area, which expands the tissues and separates the nerve roots from other tissues, will be seen on ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Blocked | Experimental | All participants will have single-shot interscalene brachial plexus block with same technique. There is no comparing. Receives: Procedure: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter change
Optic nerve sheath diameter will be measured as a unit of millimeter.
Measured: Optic nerve sheath diameter will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute and change between basal and 20th minute will be assessed
Internal jugular vein collapsibility index (IJV-CI) change
IJV-CI will be measured as a unit of %.
Measured: IJV-CI will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Maximum diameter of internal jugular vein (Dmax) change
Dmax will be measured as a unit of millimeter
Measured: Dmax will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Minimum diameter of internal jugular vein (Dmin) change
Dmin will be measured as a unit of millimeter
Measured: Dmin will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start25 Feb 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus BlockStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Assist. Prof, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434975
- Sponsor's protocol ID
- OGundogdu
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Interscalene Block on Intracranial Pressure by Sonographic Measurements of Optic Nerve Sheath Diameter and Internal Jugular Vein Collapsibility Index
- ClinicalTrials.gov ID
- NCT05434975
- Acronym / sponsor ID
- OGundogdu
- Keywords
- interscalene brachial plexus block, intracranial pressure, optic nerve sheath diameter, internal jugular vein collapsibility index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 28 Jun 2022 (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.
The study aims to show the effects of interscalene brachial plexus (ISBP) block on intracranial pressure by measuring optic nerve sheath diameter (ONSD) and internal vein collapsibility index (IJV-CI).
Detailed description
40 is the targeted number of patients who are going to have humerus fracture or opened rotator-cuff surgery. Single shot-ISBP block with 25 ml local anesthetic will be performed as anesthetic approach for surgery to all participants. Intraoperative ONSD and IJV-CI measurements will be performed before the ISBP block, 20 minutes and 60 minutes after the block. Hypothesis; external drug-volume effect on internal jugular vein causes decreasing maximum diameter of internal jugular vein (Dmax), venous return from cranium to heart decreases, intracranial pressure can increase.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blocked | Experimental | Procedure: Interscalene brachial plexus blockAll participants will have single-shot interscalene brachial plexus block with same technique. There is no comparing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had elective humeral fracture and open rotator-cuff surgery,
- Patients aged 18-85 years,
- Patients have ASA I-II anesthesia risk according to the American Society of Anesthesiologists (ASA) risk classification,
- Patients that gave consent for participation in the study will be included.
Key exclusion criteria (15 listed)
- Patients who do not give consent to the study,
- Patients with infection and open wounds in the area of skin puncture and eyelids,
- Patients have any history of intracranial pathology,
- Patients have nerve blockade contraindications such as coagulation disorder and antithrombotic-anticoagulant use,
- Patients have a history of allergy to one of the study drugs,
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 brachial plexus blockFor single shot-ISBP block, 15 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine, a total of 25 ml of local anesthetic, will be administered to all patients. For the block procedure, an imaginary horizontal line drawn from the thyroid cartilage to the sternocleidomastoid (SCM) muscle will followed and the lateral of the SCM muscle will be cleaned with povidine iodine. At the C6 level to be blocked, the nerve roots will be detected by ultrasound. 25 ml of local anesthetic will be injected around the plexus roots with a 22 G 80 mm echogenic needle. The distribution of the local anesthetic applied to the area, which expands the tissues and separates the nerve roots from other tissues, will be seen on ultrasound. | Procedure or surgery | Blocked |
Primary outcome
Optic nerve sheath diameter change
Time frame: Optic nerve sheath diameter will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute and change between basal and 20th minute will be assessed
Optic nerve sheath diameter will be measured as a unit of millimeter.
Internal jugular vein collapsibility index (IJV-CI) change
Time frame: IJV-CI will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
IJV-CI will be measured as a unit of %.
Maximum diameter of internal jugular vein (Dmax) change
Time frame: Dmax will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Dmax will be measured as a unit of millimeter
Minimum diameter of internal jugular vein (Dmin) change
Time frame: Dmin will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Dmin will be measured as a unit of millimeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Oğuz Gündoğdu, Assist. Prof principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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 brachial plexus block in people with Brachial Plexus Block and Intracranial Pressure Increase, run by Cumhuriyet University 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 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 28 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oğuz Gündoğdu (+905545945469, oguzgundogdu87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter change (time frame: Optic nerve sheath diameter will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute and change between basal and 20th minute will be assessed). The study lists 4 primary outcomes in all. 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 28 Jun 2022.