Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia (MEAV 95)
Primary Purpose
Shoulder Pain
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dose of of ropivacaine 0.75% used in block procedure
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring ISPB, Brachial Plexus Block, Anesthesia, Pain Management, Surgery
Eligibility 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
Sites / Locations
- Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Local Anesthestic Dose
Arm Description
Outcomes
Primary Outcome Measures
MEAV95 of ropivacaine 0.75%
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
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
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
Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery
Complications
Complications: Hoarseness, Horner's syndrome, intravascular injection
Pain Scores on Visual Analog Scale
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
Total opioid consumption until discharge
Opioid related side effects
Opioid related side effects: nausea, vomiting, dizziness, pruritis
Time to first analgesic use
Time to first analgesic use in hospital and after discharge
Full Information
NCT ID
NCT01703130
First Posted
October 4, 2012
Last Updated
May 29, 2014
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01703130
Brief Title
Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
Acronym
MEAV 95
Official Title
Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
ISPB, Brachial Plexus Block, Anesthesia, Pain Management, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local Anesthestic Dose
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Dose of of ropivacaine 0.75% used in block procedure
Primary Outcome Measure Information:
Title
MEAV95 of ropivacaine 0.75%
Description
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
Time Frame
30 minutes post injection
Secondary Outcome Measure Information:
Title
Motor blockade
Description
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)
Time Frame
30 minutes
Title
Bedside spirometry
Description
Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery
Time Frame
30 minutes post block, 30min post-surgery, and 2 hours post surgery
Title
Diaphragmatic excursion
Description
Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery
Time Frame
30 minutes post block, and 2 hours post surgery
Title
Complications
Description
Complications: Hoarseness, Horner's syndrome, intravascular injection
Time Frame
30 minutes
Title
Pain Scores on Visual Analog Scale
Description
Visual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
Time Frame
at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
Title
Total opioid consumption until discharge
Description
Total opioid consumption until discharge
Time Frame
24 hours (at discharge)
Title
Opioid related side effects
Description
Opioid related side effects: nausea, vomiting, dizziness, pruritis
Time Frame
24 hours (at discharge)
Title
Time to first analgesic use
Description
Time to first analgesic use in hospital and after discharge
Time Frame
within 24 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin McCartney
Phone
(416) 480-6100
Email
colin.mccartney@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin McCartney
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Choi
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jane Wang
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Moein Tavakkoli Zadeh
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin McCartney
12. IPD Sharing Statement
Links:
URL
http://sunnybrook.ca/research/
Description
Facility website
Learn more about this trial
Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
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