Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07338916

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

Led by Hospital del Trabajador de Santiago · Updated on 2026-04-08

55

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the minimum effective volume (MEV90) of local anesthetic needed to block the supraclavicular nerves with a single ultrasound-guided interscalene brachial plexus block. These nerves provide sensation to the skin over the clavicle and shoulder and can affect pain after shoulder or clavicle surgery. The study aims to optimize pain relief while reducing risks associated with local anesthetic use. Participants receive a single-shot interscalene block using bupivacaine 0.5% with epinephrine, injected between the anterior and middle scalene muscles at the C5-C6 nerve roots under ultrasound guidance. The initial volume is 12 mL, adjusted in 2 mL steps up to a maximum of 30 mL according to a dose-finding design. Experienced anesthesiologists perform all blocks following safety protocols. During the study, participants are monitored closely with ECG, oxygen saturation, and blood pressure checks. Researchers assess sensory and motor block onset and effectiveness up to 30 minutes after the block, as well as pain during the procedure and any adverse events. The main outcome is identifying the minimum volume providing effective supraclavicular nerve block to guide future pain management strategies in shoulder surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ASA physical status I to III
  • Body Mass Index (BMI) between 18 and 35 kg/m²
  • Weight at least 50 kg
  • Scheduled for shoulder arthroscopy requiring an interscalene brachial plexus block for analgesia
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment event

Participants receive a single ultrasound-guided interscalene brachial plexus block with bupivacaine to achieve sensory block of the supraclavicular nerves as part of perioperative analgesia for shoulder arthroscopy.

1 visit (in-person) at the time of block procedure

Follow-up

Duration - Up to a few hours on the day of surgery

Participants are monitored for sensorimotor block effectiveness, pain, and any block-related adverse events during and shortly after the procedure until the end of surgery.

Continuous monitoring during and immediately after the block procedure until surgery ends

Trial Site Locations

Total: 1 location

1

Hospital del Trabajador

Providencia, Chile

Actively Recruiting

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Research Team

G

Germán Aguilera, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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