Disorder of Rotator CuffNCT01730573
Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair
A study testing interscalene block and Suprascapular and Axillary nerve block in people with Disorder of Rotator Cuff, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Rotator Cuff
- What is being tested?
- interscalene block and Suprascapular and Axillary nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2012to Aug 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective shoulder arthroscopic rotator cuff repair
- ASA I - III (American Society of Anaesthesia Classification)
Who cannot join
- ASA IV or higher ( American Society of Anaesthesia Classification)
- Obesity: BMI >35
- Narcotic Abuse/ Drug dependency
- Major Neurologic deficits
- Allergy to local anesthetics
- Infection in the site of the puncture
- Mental impairment
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Health Care
London, Ontario, N6A 4V5
St. Joseph Hospital
London, Ontario
About this study
Official title: A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair
Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.
Read the detailed description
Patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups.
Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.
Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.
Performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction.
Primary hypothesis:
- Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair.
Secondary hypothesis
- Interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.
- Conditions
- Disorder of Rotator Cuff
- Being tested
- interscalene block, Suprascapular and Axillary nerve block
- Keywords
- interscalene, suprascapular, axillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene blockProcedure or surgery
This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
Suprascapular and Axillary nerve blockProcedure or surgery
This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block | Active comparator | This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided. Receives: Procedure: interscalene block |
| Suprascapular and Axillary nerve block | Active comparator | This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided. Receives: Procedure: Suprascapular and Axillary nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Efficacy
Visual Analogue scores for pain will be analyzed using chi-squared test. Interscalene block (ISB) of the brachial plexus has been demonstrated to be one of the most effective analgesic modality during arthroscopic shoulder surgery. However, despite its (ISB) time-tested record of relative safety, ISB is associated with some complications. These could be central nervous system, respiratory and cardiovascular complications. These side effects and complications are based upon the anatomy of the brachial plexus at this level.Recently, suprascapular and axillary nerve blocks have been used to control postoperative shoulder pain. The study will try to find out whether combined supra scapular and axillary nerve blocks are as effective in pain control as compared to inter scalene block.
Measured: one year
Secondary outcomes (1)
Side effects
The study will try to find out whether combined supra scapular and axillary nerve blocks are associated with less side effects as compared to inter scalene block.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Rotator CuffStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, MD, FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730573
- Sponsor's protocol ID
- 102994
- Status last verified
- Feb 2017
- First submitted
- 9 Nov 2012
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT01730573
- Acronym / sponsor ID
- 102994
- Conditions
- Disorder of Rotator Cuff
- Keywords
- interscalene, suprascapular, axillary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 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.
Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.
Detailed description
Patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups.
Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.
Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.
Performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction.
Primary hypothesis:
- Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair.
Secondary hypothesis
- Interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Active comparator | Procedure: interscalene blockThis arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided. |
| Suprascapular and Axillary nerve block | Active comparator | Procedure: Suprascapular and Axillary nerve blockThis arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective shoulder arthroscopic rotator cuff repair
- ASA I - III (American Society of Anaesthesia Classification)
Key exclusion criteria (7 listed)
- ASA IV or higher ( American Society of Anaesthesia Classification)
- Obesity: BMI >35
- Narcotic Abuse/ Drug dependency
- Major Neurologic deficits
- Allergy to local anesthetics
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 |
|---|---|---|
| interscalene blockThis arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided. | Procedure or surgery | Interscalene block |
| Suprascapular and Axillary nerve blockThis arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided. | Procedure or surgery | Suprascapular and Axillary nerve block |
Primary outcome
Analgesic Efficacy
Time frame: one year
Visual Analogue scores for pain will be analyzed using chi-squared test. Interscalene block (ISB) of the brachial plexus has been demonstrated to be one of the most effective analgesic modality during arthroscopic shoulder surgery. However, despite its (ISB) time-tested record of relative safety, ISB is associated with some complications. These could be central nervous system, respiratory and cardiovascular complications. These side effects and complications are based upon the anatomy of the brachial plexus at this level.Recently, suprascapular and axillary nerve blocks have been used to control postoperative shoulder pain. The study will try to find out whether combined supra scapular and axillary nerve blocks are as effective in pain control as compared to inter scalene block.
1 secondary outcome
Side effects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Disorder of Rotator Cuff
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Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, and Function
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Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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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.
Shalini Dhir, MD, FRCPC principal investigator
Western University, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene block and Suprascapular and Axillary nerve block in people with Disorder of Rotator Cuff, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Efficacy (time frame: one year). 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 14 Feb 2017.