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Suprascapular and Axillary Blocks Versus Interscalene Block for Shoulder Surgery (PASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517437
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The purpose of this study is to determine whether the combination of suprascapular and axillary nerve blocks is non-inferior to the conventional interscalene block (ISB) in providing pain relief during the first postoperative day to adult healthy patients (age > 18) undergoing ambulatory shoulder surgery.

Condition or disease Intervention/treatment Phase
Shoulder Pain Drug: Suprascapular & axillary blocks Drug: Interscalene block Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rest pain at additional time points [ Time Frame: 0, 6, 12, 18, and 24 hours postoperatively ]
  2. 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.


Other Outcome Measures:
  1. Hemodynamic side effect [ Time Frame: 24 hours ]
    Hemodynamic side effects, defined as occurrence of bradycardia or hypo-tension.

  2. Block success [ Time Frame: 24 hours ]
    Block success is defined as complete sensory block over the deltoid.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consented, English-speaking, adult patients (age > 18)
  • American Society of Anesthesiologists (ASA) classification I-III
  • BMI ≤ 30 kg/m2

Exclusion Criteria:

  • Total shoulder arthroplasty or clavicular surgery (ISB does not provide sufficient pain relief)
  • Known broncho-pulmonary or phrenic pathology compromising respiratory function
  • Contra-indication to nerve blocks e.g., infection, bleeding diathesis, allergy to local anesthetics
  • Existing chronic pain disorders or history of use of ≥ 30mg oxycodone or equivalent per day
  • Pre-existing neurological deficits or peripheral neuropathy involving the operative upper extremity
  • Contraindication to any component of multi-modal analgesia (acetaminophen, non-steroidal anti-inflammatory medications, oral opioid analgesics)
  • Pregnancy or any significant psychiatric conditions that may affect patient assessment

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Toronto Western Hopspital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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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
Publications:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02517437    
Other Study ID Numbers: REB14-8557-A
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations