This study aims to determine the minimum effective volume (MEV90) of local anesthetic required to achieve sensory block of the supraclavicular nerves when performing a single-shot ultrasound-guided interscalene brachial plexus block (ISB). These nerves provide sensation to the skin over the clavicle and shoulder and are often involved in surgeries such as shoulder arthroscopy and clavicle repair.
This prospective dose-finding study seeks to determine the minimum effective volume (MEV90) of local anesthetic required to achieve sensory block of the supraclavicular nerves following a single-shot ultrasound-guided interscalene brachial plexus block (ISB). These nerves, branches of the superficial cervical plexus, provide cutaneous innervation over the clavicle and shoulder and may contribute to postoperative pain after shoulder and clavicular surgery. Establishing MEV90 is clinically relevant to optimize analgesia while minimizing the risk of local anesthetic systemic toxicity. The study employs a biased coin up-and-down sequential design, commonly used in regional anesthesia dose-finding trials. The initial volume is 12 mL of bupivacaine 0.5% with epinephrine (5 µg/mL), with subsequent volumes adjusted in 2 mL increments based on the prior patient's response. The maximum permitted volume is 30 mL. All blocks are performed under ultrasound guidance by experienced anesthesiologists (≥60 ISBs), following standard safety protocols. This intervention does not introduce additional risk beyond routine care, as ISB is the gold standard for shoulder surgery analgesia. Results will inform whether a single interscalene injection provides adequate coverage of supraclavicular nerves or if a separate cervical plexus block is necessary for procedures involving both plexuses, such as clavicle surgery. Findings may refine volume recommendations, improve analgesic strategies, and reduce unnecessary drug exposure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
55
Participants will receive a single-shot interscalene brachial plexus block performed under real-time ultrasound guidance. The block targets the C5-C6 nerve roots between the anterior and middle scalene muscles using an in-plane technique. The local anesthetic is bupivacaine 0.5% with epinephrine (5 µg/mL). The injected volume ranges from 12 mL to 30 mL, determined by a dose-finding algorithm (biased coin up-and-down sequential design) to calculate the minimum effective volume (MEV90) for supraclavicular nerve block. All procedures are performed by experienced anesthesiologists following standard safety protocols, including incremental injection with aspiration and continuous monitoring (ECG, SpO₂, non-invasive blood pressure).
Minimum Effective Volume (MEV90) for Supraclavicular Nerve Block via Interscalene Approach
The primary outcome is the calculation of the minimum effective volume of local anesthetic (MEV90) required to achieve complete sensory block of the supraclavicular nerves following a single-shot ultrasound-guided interscalene brachial plexus block. Success is defined as absence of cold and touch sensation at the midpoint of the clavicle, assessed using an ice test.
Time frame: 30 minutes after completion of the block
Sensorimotor Block Score for Interscalene Block
Composite score (0-8 points) assessing sensory and motor block in C5-C6 dermatomes using ice test and motor function (shoulder abduction and external rotation). Success defined as ≥6 points.
Time frame: Every 5 minutes up to 30 minutes after block completion.
Onset Time of Sensorimotor Block
Interval (minutes) between completion of local anesthetic injection and achievement of ≥6 points on the sensorimotor scale.
Time frame: Up to 30 minutes after block completion.
Sensory Block at Shoulder Arthroscopy Portals
Presence or absence of cold and touch sensation at anterior, lateral, and posterior portal sites using ice test.
Time frame: 30 minutes after block completion.
Sensory Block of Auricular, Occipital, and Transverse Cervical Nerves
Assessment of sensory block in territories of auricular major, occipital minor, and transverse cervical nerves using ice test.
Time frame: 30 minutes after block completion.
Pain Score During Block Procedure
Patient-reported pain during needle insertion and injection, measured using Visual Analog Scale (VAS, 0-10).
Time frame: Immediately after block completion.
Block Performance Times
Time intervals for image acquisition, needle placement, and total block execution (minutes).
Time frame: During block procedure.
Incidence of Block-Related Adverse Events
Occurrence of complications including Horner's syndrome, hoarseness, dyspnea, vascular puncture, hematoma, paresthesia, and symptoms of local anesthetic systemic toxicity (LAST).
Time frame: From block completion until end of surgery.
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