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The Effect of Interscalene Block on Intracranial Pressure

Primary Purpose

Brachial Plexus Block, Intracranial Pressure Increase

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Interscalene brachial plexus block

About this trial

This is an interventional other trial for Brachial Plexus Block focused on measuring interscalene brachial plexus block, intracranial pressure, optic nerve sheath diameter, internal jugular vein collapsibility index

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sivas Cumhuriyet UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blocked

Arm Description

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

Outcomes

Primary Outcome Measures

Optic nerve sheath diameter change

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

Internal jugular vein collapsibility index (IJV-CI) change

IJV-CI will be measured as a unit of %.

Maximum diameter of internal jugular vein (Dmax) change

Dmax will be measured as a unit of millimeter

Minimum diameter of internal jugular vein (Dmin) change

Dmin will be measured as a unit of millimeter

Secondary Outcome Measures

Full Information

NCT ID

NCT05434975

First Posted

June 16, 2022

Last Updated

June 22, 2022

Sponsor

Cumhuriyet University

1. Study Identification

Unique Protocol Identification Number

NCT05434975

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 25, 2022 (Actual)

Primary Completion Date

August 15, 2022 (Anticipated)

Study Completion Date

September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brachial Plexus Block, Intracranial Pressure Increase

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blocked

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Interscalene brachial plexus block

Intervention Description

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.

Primary Outcome Measure Information:

Title

Optic nerve sheath diameter change

Description

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

Time Frame

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

Title

Internal jugular vein collapsibility index (IJV-CI) change

Description

IJV-CI will be measured as a unit of %.

Time Frame

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

Title

Maximum diameter of internal jugular vein (Dmax) change

Description

Dmax will be measured as a unit of millimeter

Time Frame

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

Title

Minimum diameter of internal jugular vein (Dmin) change

Description

Dmin will be measured as a unit of millimeter

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oğuz Gündoğdu

Phone

+905545945469

oguzgundogdu87@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oğuz Gündoğdu, Assist. Prof

Organizational Affiliation

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sivas Cumhuriyet University

City

Sivas

ZIP/Postal Code

58000

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oğuz Gündoğdu, Assist. Prof

Phone

+905545945469

droguzgundogdu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Interscalene Block on Intracranial Pressure

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