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NCT Number: NCT07338916

Dose-Finding Study: MEV90 for Local Anesthetic in Interscalene Block for Supraclavicular Nerves Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Trabajador

Providencia, Chile

Location status: Recruiting

Location contact

Germán Aguilera, MD

CONTACT

+56985205514

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • ASA physical status I to III
  • Body Mass Index (BMI) between 18 and 35 kg/m²
  • Weight ≥ 50 kg
  • Scheduled for shoulder arthroscopy requiring an interscalene brachial plexus block for analgesia
  • Able to provide informed consent

Exclusion criteria

  • Inability to provide informed consent
  • Coagulopathy (platelet count ≤100,000; INR ≥1.4)
  • Significant pulmonary disease (restrictive or obstructive)
  • Renal insufficiency (creatinine ≥1.2 mg/dL)
  • Hepatic insufficiency (transaminases ≥100 U/L)
  • Allergy to local anesthetics
  • Pregnancy
  • Pre-existing neuropathy
  • Previous surgery in ipsilateral cervical or supraclavicular region
  • Contralateral hemidiaphragmatic paralysis or vocal cord paralysis

Treatment and study plan

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).

Primary outcomes

  1. Minimum Effective Volume (MEV90) for Supraclavicular Nerve Block via Interscalene Approach

    Time frame: 30 minutes after completion of the block

    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.

Secondary outcomes

  1. Sensorimotor Block Score for Interscalene Block

    Time frame: Every 5 minutes up to 30 minutes after block completion.

    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.

  2. Onset Time of Sensorimotor Block

    Time frame: Up to 30 minutes after block completion.

    Interval (minutes) between completion of local anesthetic injection and achievement of ≥6 points on the sensorimotor scale.

  3. Sensory Block at Shoulder Arthroscopy Portals

    Time frame: 30 minutes after block completion.

    Presence or absence of cold and touch sensation at anterior, lateral, and posterior portal sites using ice test.

  4. Sensory Block of Auricular, Occipital, and Transverse Cervical Nerves

    Time frame: 30 minutes after block completion.

    Assessment of sensory block in territories of auricular major, occipital minor, and transverse cervical nerves using ice test.

  5. Pain Score During Block Procedure

    Time frame: Immediately after block completion.

    Patient-reported pain during needle insertion and injection, measured using Visual Analog Scale (VAS, 0-10).

  6. Block Performance Times

    Time frame: During block procedure.

    Time intervals for image acquisition, needle placement, and total block execution (minutes).

  7. Incidence of Block-Related Adverse Events

    Time frame: From block completion until end of surgery.

    Occurrence of complications including Horner's syndrome, hoarseness, dyspnea, vascular puncture, hematoma, paresthesia, and symptoms of local anesthetic systemic toxicity (LAST).

Study contacts

Contact information is provided by the study sponsor or research team.

Germán Aguilera, MD

CONTACT

[email protected]

+56985205514

Sponsors and collaborators

Lead sponsor

Hospital del Trabajador de Santiago

Other

Registry information

Official study title

Minimum Effective Volume (MEV90) of Local Anesthetic Required for Ultrasound-Guided Interscalene Block for Supraclavicular Nerve Block: A Dose-Finding Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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