Clinical trial NCT05434975: The Effect of Interscalene Block on Intracranial Pressure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brachial Plexus Block
Intracranial Pressure Increase
Keywords: interscalene brachial plexus block
intracranial pressure
optic nerve sheath diameter
internal jugular vein collapsibility index
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Optic nerve sheath diameter change
timeFrame: 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
measure: Internal jugular vein collapsibility index (IJV-CI) change
timeFrame: 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
measure: Maximum diameter of internal jugular vein (Dmax) change
timeFrame: 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
measure: Minimum diameter of internal jugular vein (Dmin) change
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References: