The Effect of Interscalene Block on Intracranial Pressure

NCT ID: NCT05434975

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2022-09-15

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.

Conditions

Brachial Plexus Block; Intracranial Pressure Increase

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blocked

All participants will have single-shot interscalene brachial plexus block with same technique. There is no comparing.

Group Type: EXPERIMENTAL

Interscalene brachial plexus block

Intervention Type: PROCEDURE

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.

Interventions

Interscalene 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Oguz Gundogdu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oğuz Gündoğdu, Assist. Prof

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Locations

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Oğuz Gündoğdu

Role: CONTACT

oguzgundogdu87@gmail.com

+905545945469

Facility Contacts

Oğuz Gündoğdu, Assist. Prof

Role: primary

droguzgundogdu@gmail.com

+905545945469

Other Identifiers

OGundogdu

Identifier Type: -

Identifier Source: org_study_id