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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01703130
Acronym
MEAV 95
Enrollment
60
Registered
2012-10-10
Start date
2012-10-31
Completion date
2014-12-31
Last updated
2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

ISPB, Brachial Plexus Block, Anesthesia, Pain Management, Surgery

Brief 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.

Interventions

PROCEDUREDose of of ropivacaine 0.75% used in block procedure

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective arthroscopic shoulder surgery in the sitting position * Patients aged \>=18 and \<=75 years * ASA I-III

Exclusion criteria

* Patient refusal for surgery under ISBPB with sedation * Lack of capacity to provide informed consent * Pre-existing COPD, unstable asthma or diaphragmatic dysfunction * Coagulopathy * Infection at injection site * Allergy to local anesthetics * Opioid tolerance (\>30mg oral morphine or equivalent/day for \>1 week) * BMI\>40 * Inability to complete questionnaires and assessments (consent, follow-up phone call) due to language barrier * Pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
MEAV95 of ropivacaine 0.75%30 minutes post injectionto determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic

Secondary

MeasureTime frameDescription
Bedside spirometry30 minutes post block, 30min post-surgery, and 2 hours post surgeryBedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery
Diaphragmatic excursion30 minutes post block, and 2 hours post surgeryDiaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery
Complications30 minutesComplications: Hoarseness, Horner's syndrome, intravascular injection
Motor blockade30 minutesThe C5 myotome covers the deltoid muscle (the most powerful motion being shoulder abduction) and the biceps brachii muscle. Biceps brachii is also innervated by C6. Therefore, motor blockade will be assessed by testing shoulder abduction and forearm flexion. Motor function will be classified as present (any movement) or absent (no movement)
Total opioid consumption until discharge24 hours (at discharge)Total opioid consumption until discharge
Opioid related side effects24 hours (at discharge)Opioid related side effects: nausea, vomiting, dizziness, pruritis
Time to first analgesic usewithin 24 hours post surgeryTime to first analgesic use in hospital and after discharge
Pain Scores on Visual Analog Scaleat baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until dischargeVisual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge

Countries

Canada

Contacts

Primary ContactColin McCartney
colin.mccartney@sunnybrook.ca(416) 480-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026