The Effect of Interscalene Block on Intracranial Pressure

NCT05434975 | Unknown DMC

• 1 other identifier: OGundogdu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Brachial Plexus Block; Intracranial Pressure Increase

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Optic nerve sheath diameter change

  Optic nerve sheath diameter will be measured as a unit of millimeter.

  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 %.

  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

  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

  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

Study Arms (1)

Blocked

EXPERIMENTAL

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

Procedure: Interscalene brachial plexus block

Interventions

Interscalene brachial plexus block 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.

Blocked

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Oğuz Gündoğdu, Assist. Prof

  Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oğuz Gündoğdu

CONTACT

+905545945469; oguzgundogdu87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 28, 2022
• Study Start: February 25, 2022
• Primary Completion: August 15, 2022
• Study Completion: September 15, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)