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| ID | Type | Description | Link |
|---|---|---|---|
| 251213001 | Other Identifier | Comité Ético Científico de Ciencias de la Salud - Universidad Católica |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimum Effective Volume 90 (MEV90) | Experimental | Participants in this arm will receive a single-shot ultrasound-guided interscalene brachial plexus block as part of standard perioperative analgesia for shoulder arthroscopy. The intervention consists of injecting bupivacaine 0.5% with epinephrine (5 µg/mL) between the anterior and middle scalene muscles at the level of the C5-C6 nerve roots, using an in-plane technique under real-time ultrasound guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Interscalene Block with Bupivacaine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes after completion of the block |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 5 minutes up to 30 minutes after block completion. |
| Onset Time of Sensorimotor Block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Germán Aguilera, MD | Contact | +56985205514 | german.aguilera@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Trabajador | Recruiting | Providencia | Chile |
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Interval (minutes) between completion of local anesthetic injection and achievement of ≥6 points on the sensorimotor scale. |
| 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. | 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. | 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). | Immediately after block completion. |
| Block Performance Times | Time intervals for image acquisition, needle placement, and total block execution (minutes). | 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). | From block completion until end of surgery. |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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