Evaluation of Supraclavicular Brachial Plexus Blocks at Various Volumes: Impact on Optic Nerve Sheath Diameter

NCT06428461 | Completed

• 1 other identifier: PAU-ANEST-RHE-IC-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative pain relief effectiveness of supraclavicular brachial plexus blocks administered at different volumes under ultrasound guidance. Additionally, the investigators utilized ultrasound to measure optic nerve sheath diameters and investigated their relationship with intracranial pressure across varying block volumes.

Conditions

Upper Limb Injury; Intracranial Pressure Increase

Keywords

Supraclavicular brachial plexus block; Intracranial pressure; Optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter measured by ultrasonography

  Optic nerve sheath diameter will be measured using B-mode ultrasonography.

  Before block, After block 20 minutes, After block 60 minutes

Secondary Outcomes (5)

• Perfusion index (PI)

  The PI values will be measured and recorded at 0, 2, 4, 6, 8, 10, 15, 20, and 25 minutes in both arms.

• Non-invazive end-tidal carbon dioxide (EtCO2)

  EtCO2 will be measured and recorded at 0, 10, 20, 30, 60 minutes, and at the end of surgery after the block is performed.

• Pinprick test

  The pinprick test will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations.

• Modified Bromage Scale

  The Modified Bromage Scale will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations.

• Verbal Pain Score

  The Verbal Pain Score will be assessed at the following intervals after surgery: immediately in the recovery room, at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.

Study Arms (4)

Total of 15 mL.

ACTIVE COMPARATOR

For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 7.5 mL of 2% prilocaine (PRİLOC®) for a total of 15 mL. single shot supraclavicular brachial plexus block.

Procedure: Supraclavicular brachial plexus block; Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound; Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement; Device: End-Tidal Carbon Dioxide (EtCO2) Measurement

Total of 20 mL.

ACTIVE COMPARATOR

For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine (BUVİCAİNE®) and 10 mL of 2% prilocaine (PRİLOC®) for a total of 20 mL.

Procedure: Supraclavicular brachial plexus block; Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound; Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement; Device: End-Tidal Carbon Dioxide (EtCO2) Measurement

Total of 25 mL.

ACTIVE COMPARATOR

For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 12.5 mL of 2% prilocaine (PRİLOC®) for a total of 25 mL.

Procedure: Supraclavicular brachial plexus block; Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound; Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement; Device: End-Tidal Carbon Dioxide (EtCO2) Measurement

Total of 30 mL.

ACTIVE COMPARATOR

For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine (BUVİCAİNE®) and 15 mL of 2% prilocaine (PRİLOC®) for a total of 30 mL.

Procedure: Supraclavicular brachial plexus block; Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound; Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement; Device: End-Tidal Carbon Dioxide (EtCO2) Measurement

Interventions

Supraclavicular brachial plexus block PROCEDURE

A supraclavicular brachial plexus block will be performed under ultrasound guidance. The patient will be taken to the preoperative block room, positioned supine with the bed elevated at a 30° angle, and the head turned away from the arm being blocked. To avoid intraneural injection, the block will use both ultrasound and a nerve stimulator (Plexygon, Vygon-Italy) with a 22G 50 mm 20° stimulating needle (Echoplex, Braun-France). A low-frequency ultrasound probe will be placed above the clavicle to visualize the subclavian artery and vein. Using an in-plane approach, the needle will be inserted laterally to medially from the mid-clavicular point through the skin and subcutaneous tissue. Under ultrasound guidance, the needle will be advanced towards the anatomical corner where the brachial plexus and subclavian artery are adjacent (corner pocket), and a local anesthetic agent will be injected to perform the block.

Total of 15 mL.; Total of 20 mL.; Total of 25 mL.; Total of 30 mL.

Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound DEVICE

Before the block, both eyes will be measured for optic nerve sheath diameter (ONSD) using B-mode ultrasound (USG) with a GE LOGIQ E device. The patient will be supine with the bed elevated at a 30° angle, eyes closed, and a protective barrier applied. Both globes will be filled with water-soluble ultrasound gel, and imaging will be done with a 7.5 MHz linear probe at a 7 cm depth. For transverse ONSD measurement, the probe will be placed transversely in the coronal plane, with the marker notch pointing right. When the optic nerve entry into the globe is clear, transverse ONSD will be measured 3 mm below. For sagittal measurement, the probe will be placed sagittally in the coronal plane, with the marker notch pointing towards the body. Sagittal ONSD will be measured 3 mm below the entry point. Both internal and external diameters of the optic nerve sheath will be measured in transverse and sagittal planes, and the transverse diameter of the globe will also be measured.

Total of 15 mL.; Total of 20 mL.; Total of 25 mL.; Total of 30 mL.

Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement DEVICE

Investigator plan to measure the Perfusion Index (PI) as an objective method for determining the success of peripheral nerve blocks, different from traditional tests. PI is an indicator of peripheral perfusion that can be continuously measured non-invasively with a pulse oximeter. PI represents the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. The Mindray uMEC 12 device will be used for this measurement.

Total of 15 mL.; Total of 20 mL.; Total of 25 mL.; Total of 30 mL.

End-Tidal Carbon Dioxide (EtCO2) Measurement DEVICE

End-tidal carbon dioxide (EtCO2) measurement: The Medtronic Capnostream 35 device will be used for EtCO2 measurements. All patients will receive oxygen support at a rate of 1-2 L/min. If peripheral oxygen saturation falls below 95%, oxygen support will be increased to 3-6 L/min via nasal cannula.

Total of 15 mL.; Total of 20 mL.; Total of 25 mL.; Total of 30 mL.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 50, of both genders, with planned surgery on the finger, wrist, elbow joint, and distal region, and classified as ASA I-II, will be included in the study. In this study, patients will be informed about the anesthesia method and the tests to be conducted, and those who consent will be asked to sign an informed consent form as voluntary participants.

You may not qualify if:

• Patients who do not accept the procedures and tests
• Those with diseases that may cause increased intracranial pressure
• Patients with severe heart failure
• Patients with second or third degree atrioventricular block
• Patients with unstable angina history
• Patients with COPD and chronic asthma
• Patients with a history of myocardial infarction (MI) within the last 6 weeks
• Patients with a heart rate below 50 beats/min
• Patients with systolic blood pressure below 90 mmHg
• Patients with liver failure
• Patients with kidney failure
• Patients for whom supraclavicular block anatomically cannot be performed
• Those with neurological or psychological diseases that make it difficult to assess the tests
• Patients allergic to any of the study drugs
• Pregnant women

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20020, Turkey (Türkiye)

Location

Related Publications (3)

• Gundogdu O, Avci O. Evaluation of the Effect of Interscalene Brachial Plexus Block on Intracranial Pressure Using Optic Nerve Sheath Diameter and Internal Jugular vein Collapsibility Index. J Coll Physicians Surg Pak. 2022 Oct;32(10):1249-1254. doi: 10.29271/jcpsp.2022.10.1249.

  PMID: 36205266 BACKGROUND

• Pansell J, Bell M, Rudberg P, Friman O, Cooray C. Optic nerve sheath diameter measurement by ultrasound: Evaluation of a standardized protocol. J Neuroimaging. 2022 Jan;32(1):104-110. doi: 10.1111/jon.12936. Epub 2021 Sep 23.

  PMID: 34555223 BACKGROUND

• Hylkema C. Optic Nerve Sheath Diameter Ultrasound and the Diagnosis of Increased Intracranial Pressure. Crit Care Nurs Clin North Am. 2016 Mar;28(1):95-9. doi: 10.1016/j.cnc.2015.10.005. Epub 2015 Dec 23.

  PMID: 26873762 BACKGROUND

MeSH Terms

Conditions

Arm Injuries; Intracranial Hypertension

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rıza Hakan Erbay

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator - Medical doctor

Model Details: Four different volumes will be administered for the supraclavicular block: 1. For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVICAINE-POLIFARMA-TEKIRDAG) and 7.5 mL of 2% prilocaine (PRILOC-VEM İlaç San. ve Tic. A.Ş. Kapaklı/TEKIRDAĞ) for a total of 15 mL. 2. For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine and 10 mL of 2% prilocaine for a total of 20 mL. 3. For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine and 12.5 mL of 2% prilocaine for a total of 25 mL. 4. For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine and 15 mL of 2% prilocaine for a total of 30 mL. Glob axis and optic nerve sheath diameter measurements for both eyes will be re-measured and recorded using B-mode ultrasound at 20 and 60 minutes after the supraclavicular block.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 24, 2024
• Study Start: May 20, 2024
• Primary Completion: August 3, 2024
• Study Completion: April 10, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)