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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Colin McCartney, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01703130
First received: October 4, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Procedure: Dose of of ropivacaine 0.75% used in block procedure
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • MEAV95 of ropivacaine 0.75% [ Time Frame: 30 minutes post injection ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Motor blockade [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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)

  • Bedside spirometry [ Time Frame: 30 minutes post block, 30min post-surgery, and 2 hours post surgery ] [ Designated as safety issue: Yes ]
    Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 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 ] [ Designated as safety issue: Yes ]
    Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery

  • Complications [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Complications: Hoarseness, Horner's syndrome, intravascular injection

  • 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 ] [ Designated as safety issue: No ]
    Visual analog scale (VAS) - 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) ] [ Designated as safety issue: No ]
    Total opioid consumption until discharge

  • Opioid related side effects [ Time Frame: 24 hours (at discharge) ] [ Designated as safety issue: No ]
    Opioid related side effects: nausea, vomiting, dizziness, pruritis

  • Time to first analgesic use [ Time Frame: within 24 hours post surgery ] [ Designated as safety issue: No ]
    Time to first analgesic use in hospital and after discharge


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Local Anesthestic Dose Procedure: Dose of of ropivacaine 0.75% used in block procedure

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703130

Contacts
Contact: Colin McCartney (416) 480-6100 colin.mccartney@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre Recruiting
Toronto, Ontario, Canada, M4Y 1H1
Principal Investigator: Colin McCartney         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Colin McCartney, Staff Anesthesiologist and Director of Research, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01703130     History of Changes
Other Study ID Numbers: 126-2012
Study First Received: October 4, 2012
Last Updated: May 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
ISPB
Brachial Plexus Block
Anesthesia
Pain Management
Surgery

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014