Suprascapular and Axillary Blocks Versus Interscalene Block for Shoulder Surgery

NCT02517437 | Completed Phase 4 DMC

• 1 other identifier: REB14-8557-A
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain severity

  Numeric rating scale (NRS) scores will be evaluated by blinded study coordinators who are not involved in patient care.

  1st post-operative 24 hours

Secondary Outcomes (2)

• Rest pain at additional time points

  0, 6, 12, 18, and 24 hours postoperatively

• Quality of Recovery (QoR)

  24 hours

Other Outcomes (3)

• Hemodynamic side effect

  24 hours

• Block success

  24 hours

• Procedural complications

  during or just after block.

Study Arms (2)

Suprascapular & axillary blocks

ACTIVE COMPARATOR

Suprascapular and axillary blocks.

Drug: Suprascapular & axillary blocks

Interscalene block

ACTIVE COMPARATOR

Interscalene block.

Drug: Interscalene block

Interventions

Suprascapular & axillary blocks DRUG

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.

Also known as: Suprascapular and axillary blocks

Suprascapular & axillary blocks

Interscalene block DRUG

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.

Interscalene block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (5)

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Voogd AC, Ververs JM, Vingerhoets AJ, Roumen RM, Coebergh JW, Crommelin MA. Lymphoedema and reduced shoulder function as indicators of quality of life after axillary lymph node dissection for invasive breast cancer. Br J Surg. 2003 Jan;90(1):76-81. doi: 10.1002/bjs.4010.

  PMID: 12520579 BACKGROUND

• Peintinger F, Reitsamer R, Stranzl H, Ralph G. Comparison of quality of life and arm complaints after axillary lymph node dissection vs sentinel lymph node biopsy in breast cancer patients. Br J Cancer. 2003 Aug 18;89(4):648-52. doi: 10.1038/sj.bjc.6601150.

  PMID: 12915872 BACKGROUND

• Lo IK, Litchfield RB, Griffin S, Faber K, Patterson SD, Kirkley A. Quality-of-life outcome following hemiarthroplasty or total shoulder arthroplasty in patients with osteoarthritis. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Oct;87(10):2178-85. doi: 10.2106/JBJS.D.02198.

  PMID: 16203880 BACKGROUND

• Gutierrez DD, Thompson L, Kemp B, Mulroy SJ; Physical Therapy Clinical Research Network; Rehabilitation Research and Training Center on Aging-Related Changes in Impairment for Persons Living with Physical Disabilities. The relationship of shoulder pain intensity to quality of life, physical activity, and community participation in persons with paraplegia. J Spinal Cord Med. 2007;30(3):251-5. doi: 10.1080/10790268.2007.11753933.

  PMID: 17684891 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)