The Effect of Interscalene Block on Intracranial Pressure

Not Applicable

• Conditions: Brachial Plexus Block; Intracranial Pressure Increase
• Interventions: Procedure: Interscalene brachial plexus block

• Registration Number: NCT05434975
• Lead Sponsor: Cumhuriyet University

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.

Study Timeline

• Study Start: 2022-02-25
• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Primary Completion: 2022-08-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blocked	Interscalene brachial plexus block	All participants will have single-shot interscalene brachial plexus block with same technique. There is no comparing.

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter change	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.
Maximum diameter of internal jugular vein (Dmax) change	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	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
Internal jugular vein collapsibility index (IJV-CI) change	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 %.

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Turkey