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

Not Applicable

Recruiting

• Conditions: Intracranial Pressure Increase; Upper Limb Injury
• Interventions: 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

• Registration Number: NCT06428461
• Lead Sponsor: Pamukkale University

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.

Study Timeline

• Study First Submitted: 2024-05-14
• Study Start: 2024-05-20
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-24
• Status Verified: 2024-06
• Primary Completion: 2024-08-03
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Study Completion: 2024-11-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total of 20 mL.	Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement	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.
Total of 15 mL.	Supraclavicular brachial plexus block	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.
Total of 15 mL.	Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement	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.
Total of 20 mL.	Supraclavicular brachial plexus block	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.
Total of 15 mL.	Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound	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.
Total of 30 mL.	End-Tidal Carbon Dioxide (EtCO2) Measurement	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.
Total of 15 mL.	End-Tidal Carbon Dioxide (EtCO2) Measurement	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.
Total of 20 mL.	End-Tidal Carbon Dioxide (EtCO2) Measurement	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.
Total of 25 mL.	End-Tidal Carbon Dioxide (EtCO2) Measurement	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.
Total of 20 mL.	Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound	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.
Total of 25 mL.	Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound	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.
Total of 25 mL.	Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement	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.
Total of 25 mL.	Supraclavicular brachial plexus block	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.
Total of 30 mL.	Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement	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.
Total of 30 mL.	Supraclavicular brachial plexus block	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.
Total of 30 mL.	Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter measured by ultrasonography	Before block, After block 20 minutes, After block 60 minutes	Optic nerve sheath diameter will be measured using B-mode ultrasonography.

Secondary Outcome Measures

Name	Time	Method
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.	The pinprick test is a clinical procedure used to evaluate sensory nerve function. A small, sharp object, such as a pin or needle, is gently pressed against the skin to assess the patient's ability to feel pain.
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.	The Verbal Pain Score is a subjective measure used to assess a patient's level of pain. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
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.	PI, an objective method different from traditional tests, to determine the success of peripheral nerve block. PI is an indicator of peripheral perfusion that can be measured continuously and non-invasively with a pulse oximeter. PI is the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. Its normal value ranges from 0.02 to 20. After peripheral nerve block, vasodilation occurs in the vessels due to sympathetic blockade, resulting in an increase in PI values, which occurs earlier than motor and sensory block. PI monitoring provides more objective results for evaluating the onset of the block. The cut-off value indicating that the block is successful is a PI increase to 3.03 times the baseline value 10 minutes after the block is administered.
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.	Non-invasive EtCO2 measurement is a method used to monitor the concentration of carbon dioxide (CO2) at the end of expiration.
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.	The Modified Bromage Scale is a clinical tool used to assess the degree of motor block in patients who have received regional anesthesia. The scale ranges from 0 to 3, with each level indicating a different degree of motor impairment: * 0: No motor block; full flexion of knees and feet.; * 1: Partial motor block; able to move knees but not feet.; * 2: Almost complete motor block; able to move feet only.; * 3: Complete motor block; unable to move knees or feet.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Pamukkale, Turkey