- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730573
Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair
A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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London, Ontario, Canada, N6A 4V5
- St. Joseph's Health Care
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London, Ontario, Canada
- St. Joseph Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective shoulder arthroscopic rotator cuff repair
- ASA I - III (American Society of Anaesthesia Classification)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interscalene block
This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
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This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
|
Active Comparator: Suprascapular and Axillary nerve block
This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
|
This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: 1 year
|
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.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shalini Dhir, MD, FRCPC, Western University, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 102994
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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