Shoulder PainPhase 4MEAV 95NCT01703130
Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
A Phase 4 study testing Dose of of ropivacaine 0.75% used in block procedure in people with Shoulder Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Dose of of ropivacaine 0.75% used in block procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective arthroscopic shoulder surgery in the sitting position
- Patients aged >=18 and <=75 years
- ASA I-III
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre
Toronto, Ontario, M4Y 1H1
Colin McCartney
About this study
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.
- Conditions
- Shoulder Pain
- Being tested
- Dose of of ropivacaine 0.75% used in block procedure
- Keywords
- ISPB, Brachial Plexus Block, Anesthesia, Pain Management, Surgery
- Medical subject headings
- Shoulder Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of of ropivacaine 0.75% used in block procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthestic Dose | Experimental | Not described Receives: Procedure: Dose of of ropivacaine 0.75% used in block procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes post injection
Secondary outcomes (8)
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)
Measured: 30 minutes
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
Measured: 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
Measured: 30 minutes post block, and 2 hours post surgery
Complications
Complications: Hoarseness, Horner's syndrome, intravascular injection
Measured: 30 minutes
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
Measured: 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
Measured: 24 hours (at discharge)
Opioid related side effects
Opioid related side effects: nausea, vomiting, dizziness, pruritis
Measured: 24 hours (at discharge)
Time to first analgesic use
Time to first analgesic use in hospital and after discharge
Measured: within 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dr. Colin McCartney, Sunnybrook Health Sciences Centre
- Investigators
- Colin McCartney, Principal investigator, Sunnybrook Health Sciences CentreStephen Choi, Study chair, Sunnybrook Health Sciences CentreJane Wang, Study chair, Sunnybrook Health Sciences CentreMoein Tavakkoli Zadeh, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703130
- Sponsor's protocol ID
- 126-2012
- Acronym
- MEAV 95
- Status last verified
- May 2014
- First submitted
- 4 Oct 2012
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
- ClinicalTrials.gov ID
- NCT01703130
- Acronym / sponsor ID
- MEAV 95 / 126-2012
- Conditions
- Shoulder Pain
- Keywords
- ISPB, Brachial Plexus Block, Anesthesia, Pain Management, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local Anesthestic Dose | Experimental | Procedure: Dose of of ropivacaine 0.75% used in block procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective arthroscopic shoulder surgery in the sitting position
- Patients aged >=18 and <=75 years
- ASA I-III
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose of of ropivacaine 0.75% used in block procedure | Procedure or surgery | Local Anesthestic Dose |
Primary outcome
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
8 secondary outcomes
Motor blockade
Time frame: 30 minutes
Bedside spirometry
Time frame: 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
Complications
Time frame: 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
Total opioid consumption until discharge
Time frame: 24 hours (at discharge)
Opioid related side effects
Time frame: 24 hours (at discharge)
Time to first analgesic use
Time frame: within 24 hours post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Facility websiteLink provided by the sponsor.
Related trials for Shoulder Pain
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin McCartney principal investigator
Sunnybrook Health Sciences Centre
Stephen Choi study chair
Sunnybrook Health Sciences Centre
Jane Wang study chair
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dose of of ropivacaine 0.75% used in block procedure in people with Shoulder Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin McCartney ((416) 480-6100, colin.mccartney@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEAV95 of ropivacaine 0.75% (time frame: 30 minutes post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.