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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Postoperative pain severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented, English-speaking, adult patients (age > 18)
- •American Society of Anesthesiologists (ASA) classification I-III
- •BMI ≤ 30 kg/m2
排除标准
- •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
研究组 & 干预措施
Suprascapular & axillary blocks
Suprascapular and axillary blocks.
干预措施: Suprascapular & axillary blocks (Drug)
Interscalene block
Interscalene block.
干预措施: Interscalene block (Drug)
结局指标
主要结局
Postoperative pain severity
时间窗: 1st post-operative 24 hours
Numeric rating scale (NRS) scores will be evaluated by blinded study coordinators who are not involved in patient care.
次要结局
- Quality of Recovery (QoR)(24 hours)
- Rest pain at additional time points(0, 6, 12, 18, and 24 hours postoperatively)