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

May 29, 2014 updated by: Dr. Colin McCartney, Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4Y 1H1
        • Recruiting
        • Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre
        • Principal Investigator:
          • Colin McCartney

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local Anesthestic Dose
Procedure: Dose of of ropivacaine 0.75% used in block procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEAV95 of ropivacaine 0.75%
Time Frame: 30 minutes post injection
to 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
30 minutes post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor blockade
Time Frame: 30 minutes
The 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)
30 minutes
Bedside spirometry
Time Frame: 30 minutes post block, 30min post-surgery, and 2 hours post surgery
Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery
30 minutes post block, 30min post-surgery, and 2 hours post surgery
Diaphragmatic excursion
Time Frame: 30 minutes post block, and 2 hours post surgery
Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery
30 minutes post block, and 2 hours post surgery
Complications
Time Frame: 30 minutes
Complications: Hoarseness, Horner's syndrome, intravascular injection
30 minutes
Pain Scores on Visual Analog Scale
Time Frame: at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
Visual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
Total opioid consumption until discharge
Time Frame: 24 hours (at discharge)
Total opioid consumption until discharge
24 hours (at discharge)
Opioid related side effects
Time Frame: 24 hours (at discharge)
Opioid related side effects: nausea, vomiting, dizziness, pruritis
24 hours (at discharge)
Time to first analgesic use
Time Frame: within 24 hours post surgery
Time to first analgesic use in hospital and after discharge
within 24 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Colin McCartney, Sunnybrook Health Sciences Centre
  • Study Chair: Stephen Choi, Sunnybrook Health Sciences Centre
  • Study Chair: Jane Wang, Sunnybrook Health Sciences Centre
  • Study Chair: Moein Tavakkoli Zadeh, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 5, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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