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Local Anesthetic

Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia (MEAV 95 Trial)

Phase 4
Waitlist Available
Led By Colin McCartney
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, after surgery at 30 and 60 minutes in the pacu, and at 1 hour intervals until discharge
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder surgery. However, patients can experience complications such as blurred vision, hoarseness and shortness of breath with the standard volumes of local anesthetic used in contemporary practice. Patients with respiratory diseases are precluded because of the potential effects on respiration. However, they are then exposed to the risks of general anesthesia and opioid medications which can also have detrimental effects on respiration. Ultrasound guided ISB can reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this may reduce the complications from ISB to allow patients previously unable to benefit to have this technique, such as patients with obesity and respiratory disease. In order to do so the investigators will use an up-down methodology to find the minimum volume of local anesthetic to provide sufficient anesthesia for shoulder surgery.

Eligible Conditions
  • Shoulder Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, after surgery at 30 and 60 minutes in the pacu, and at 1 hour intervals until discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, after surgery at 30 and 60 minutes in the pacu, and at 1 hour intervals until discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MEAV95 of ropivacaine 0.75%
Secondary study objectives
Bedside spirometry
Complications
Diaphragmatic excursion
+5 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Local Anesthestic DoseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,836 Total Patients Enrolled
1 Trials studying Shoulder Pain
64 Patients Enrolled for Shoulder Pain
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,343 Total Patients Enrolled
1 Trials studying Shoulder Pain
275 Patients Enrolled for Shoulder Pain
Colin McCartneyPrincipal InvestigatorSunnybrook Health Sciences Centre
Stephen ChoiStudy ChairSunnybrook Health Sciences Centre
1 Previous Clinical Trials
746 Total Patients Enrolled
Jane WangStudy ChairSunnybrook Health Sciences Centre
Moein Tavakkoli ZadehStudy ChairSunnybrook Health Sciences Centre
~5 spots leftby Dec 2025