Clinical trial NCT06428461: Evaluation of Supraclavicular Brachial Plexus Blocks At Various Volumes: Impact on Optic Nerve Sheath Diameter
Official title: Evaluation of Supraclavicular Brachial Plexus Blocks At Different Volumes Under Ultrasound Guidance in Upper Extremity Surgery and Their Impact on Optic Nerve Sheath Diameter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Limb Injury
Intracranial Pressure Increase
Keywords: Supraclavicular brachial plexus block
Intracranial pressure
Optic nerve sheath diameter
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.

Detailed description: Regional anesthesia involves temporarily blocking nerve transmission and pain sensation in specific areas of the body without causing loss of consciousness. Regional anesthesia techniques include peripheral nerve blocks (PNB), topical anesthesia, infiltration anesthesia, regional intravenous anesthesia (RIVA), and neuroaxial blocks (spinal and epidural anesthesia).

Brachial plexus blocks are among the most commonly used regional anesthesia methods within peripheral nerve block applications. Peripheral nerve blocks of the upper extremity can be used either alone for surgical anesthesia or added to general anesthesia for postoperative pain control. Brachial plexus blocks can be performed using various approaches including interscalene, supraclavicular, infraclavicular, and axillary approaches.

The supraclavicular block aims to effectively control pain through a procedure targeting the shoulder and upper extremity nerves known as the brachial plexus. Complications of supraclavicular blocks may include pneumothorax secondary to lung trauma, hoarseness due to ipsilateral recurrent laryngeal nerve blockade, Horner syndrome due to stellate ganglion blockade, and hemidiaphragmatic paralysis due to phrenic nerve blockade. The incidence and severity of these complications are reduced with the use of ultrasound (USG) guidance and low-volume techniques.

Intracranial pressure (ICP) refers to the pressure formed by the brain and spinal fluid, tissues, and blood surrounding the brain and spinal cord. Normally ranging between 5-15 mmHg, this pressure is critical for brain function and circulation. Abnormal increases in intracranial pressure can lead to intracranial hypertension, with main causes including brain tumors, edema, head trauma, brain aneurysms, intracranial hemorrhage, and issues related to the production and drainage of cerebrospinal fluid. External ventricular drainage (EVD) catheterization is the gold standard method for evaluating increased intracranial pressure. Measurement of optic nerve sheath diameter (ONSD) has been described as a valuable diagnostic method in clinical applications for evaluating intracranial pressure.

Observational studies have shown that in cervical sympathetic blocks and interscalene blocks, indirect increases in intracranial pressure can be demonstrated through ultrasound (USG) measurements of optic nerve sheath diameter. It has been shown that hemidiaphragmatic paralysis due to ipsilateral phrenic nerve involvement, which is frequently seen in interscalene brachial plexus blocks, also occurs in supraclavicular brachial plexus blocks in a volume-dependent manner. There are studies in the literature on supraclavicular block applications with different volumes and doses. However, the investigators have not come across a study evaluating the clinical outcomes of optic nerve sheath diameter measurement along with anesthesia quality, side effects, and complications in ultrasound-guided supraclavicular blocks at different volumes.

In this study, the investigators aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative analgesic efficacy of supraclavicular brachial plexus blocks performed at different volumes in our clinical practice under ultrasound guidance. Additionally, the investigators aimed to measure optic nerve sheath diameters with ultrasound and establish their relationship with intracranial pressure according to these different volumes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Optic nerve sheath diameter measured by ultrasonography
timeFrame: Before block, After block 20 minutes, After block 60 minutes
Secondary outcomes:
measure: Perfusion index (PI)
timeFrame: The PI values will be measured and recorded at 0, 2, 4, 6, 8, 10, 15, 20, and 25 minutes in both arms.
measure: Non-invazive end-tidal carbon dioxide (EtCO2)
timeFrame: EtCO2 will be measured and recorded at 0, 10, 20, 30, 60 minutes, and at the end of surgery after the block is performed.
measure: Pinprick test
timeFrame: 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.
measure: Modified Bromage Scale
timeFrame: 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.
measure: Verbal Pain Score
timeFrame: 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.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Pamukkale University
name: Rıza Hakan Erbay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.