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The Effect of Interscalene Block on Intracranial Pressure

Evaluation of the Effect of Interscalene Block on Intracranial Pressure by Sonographic Measurements of Optic Nerve Sheath Diameter and Internal Jugular Vein Collapsibility Index

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05434975
Enrollment
40
Registered
2022-06-28
Start date
2022-02-25
Completion date
2022-09-15
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Block, Intracranial Pressure Increase

Keywords

interscalene brachial plexus block, intracranial pressure, optic nerve sheath diameter, internal jugular vein collapsibility index

Brief 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).

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.

Interventions

PROCEDUREInterscalene brachial plexus block

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.

Sponsors

Cumhuriyet University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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, * 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.

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter changeOptic 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 assessedOptic nerve sheath diameter will be measured as a unit of millimeter.
Internal jugular vein collapsibility index (IJV-CI) changeIJV-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 assessedIJV-CI will be measured as a unit of %.
Maximum diameter of internal jugular vein (Dmax) changeDmax 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 assessedDmax will be measured as a unit of millimeter
Minimum diameter of internal jugular vein (Dmin) changeDmin 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 assessedDmin will be measured as a unit of millimeter

Countries

Turkey (Türkiye)

Contacts

Primary ContactOğuz Gündoğdu
oguzgundogdu87@gmail.com+905545945469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026