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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Postoperative pain severity
Study Overview
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.
Detailed Description
Study Hypothesis:The pain relief provided by a combination of suprascapular and axillary nerve blocks is non-inferior to that produced by the conventional interscalene block during the first 24hours postoperatively in adult patients undergoing ambulatory shoulder surgery.
Intervention and Comparator: Consented patients will be randomized to receive either pre-operative ISB (plus sham SAB with subcutaneous saline), or SAB (plus sham ISB). Both groups will receive general anesthesia for surgery.
Primary Aim: To demonstrate non-inferiority of pain relief produced by the combination treatment compared to the conventional treatment by comparing the area under the curve of the postoperative pain scores plot over time during the first 24 hours postoperatively.
Secondary Aims: There are four secondary aims, covering efficacy (analgesia) and safety: rest pain, quality of recovery, safety, other pain relief indicators.
Design There will be a multi-centre, prospective, randomized, patient and assessor blinded, two-arm, parallel-group, 1:1 allocation ratio, placebo-controlled, non-inferiority clinical trial comparing the effect of SAB treatment to conventional ISB treatment on pain relief during the first postoperative 24 hours in patients undergoing ambulatory shoulder surgery under general anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Suprascapular & axillary blocks
Suprascapular and axillary blocks.
Intervention: Suprascapular & axillary blocks (Drug)
Interscalene block
Interscalene block.
Intervention: Interscalene block (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Quality of Recovery (QoR)(24 hours)
- Rest pain at additional time points(0, 6, 12, 18, and 24 hours postoperatively)