Suprascapular and Axillary Blocks Versus Interscalene Block for Shoulder Surgery (PASS)
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|ClinicalTrials.gov Identifier: NCT02517437|
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Drug: Suprascapular & axillary blocks Drug: Interscalene block||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Novel Combination of Suprascapular & Axillary Nerve Blocks Versus Conventional Interscalene Brachial Plexus Block for Pain Relief Following Shoulder Surgery: A Multi-centre Randomized, Patient & Assessor Blinded, Non-inferiority Trial|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Active Comparator: Suprascapular & axillary blocks
Suprascapular and axillary blocks.
Drug: Suprascapular & axillary blocks
After infiltration with 1 mL of 1% lidocaine, local anesthetics (20 mL of 0.5% ropivacaine) will then be injected in 5 mL aliquots to achieve circumferential spread around the nerve.The axillary nerve block will be performed next in the posterior aspect of the operative arm. The neurovascular bundle encompassing the humeral artery, posterior circumflex artery, and axillary nerve is visualized in the lateral edge of the quadrangular space, deep to the deltoid muscle, inferior to the teres minor muscle, and superior to the triceps tendon. After infiltration with 1 mL of 1% lidocaine, local anesthetics (20 mL of 0.5% ropivacaine) will then be injected in 5 mL aliquots after negative aspiration to achieve circumferential spread around the bundle.
Other Name: Suprascapular and axillary blocks
Active Comparator: Interscalene block
Drug: Interscalene block
After sterile skin preparation with chlorhexidine and infiltration with 1 mL of 1% lidocaine, a 5 cm 22 G insulated needle is then inserted and local anesthetic solution (20 mL of 0.5% ropivacaine) will be injected in 5 mL aliquots after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots.
- Postoperative pain severity [ Time Frame: 1st post-operative 24 hours ]Numeric rating scale (NRS) scores will be evaluated by blinded study coordinators who are not involved in patient care.
- Rest pain at additional time points [ Time Frame: 0, 6, 12, 18, and 24 hours postoperatively ]
- Quality of Recovery (QoR) [ Time Frame: 24 hours ]The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. The QoR-15 scale is a patient-based outcome measure in the form of a 15-item validated questionnaire.
- Hemodynamic side effect [ Time Frame: 24 hours ]Hemodynamic side effects, defined as occurrence of bradycardia or hypo-tension.
- Block success [ Time Frame: 24 hours ]Block success is defined as complete sensory block over the deltoid.
- Procedural complications [ Time Frame: during or just after block. ]Procedural complications are defined as occurrence of intravascular injection, local anesthetic systemic toxicity, hematoma, pneumothorax, epidural spread, and Horner's syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517437
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|
|Toronto Western Hopspital|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Vincent Chan, MD||Toronto Western Hospital, University Health Network, University of Toronto|
|Principal Investigator:||Faraj Abdallah, MD||St. Michael's Hospital, University of Toronto|
|Principal Investigator:||Richard Brull, MD||Women's College Hospital, University of Toronto|