A Randomized Comparison Between Interscalene And Combined Infraclavicular-Anterior Suprascapular Nerve Blocks For Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Static pain 30 minutes after arrival in the post anesthesia care unit (PACU)
研究概览
简要总结
Postoperative analgesia after shoulder surgery remains a challenge in patients with preexisting pulmonary pathology, as interscalene brachial plexus block (ISB), the standard nerve block for shoulder surgery, carries a prohibitive risk of hemidiaphragmatic paralysis (HDP). Although several diaphragm-sparing nerve blocks have been proposed, none seems to offer equivalent analgesia to ISB while avoiding HDP altogether. For instance, even costoclavicular blocks, which initially fulfilled both requirements, were subsequently found to result in a non-negligible 5%-incidence of HDP.
In this randomized trial, the authors set out to compare ISB and combined infraclavicular block-anterior suprascapular nerve blocks (ICB-ASSNB) for patients undergoing arthroscopic shoulder surgery. The authors hypothesized that ICB-ASSNB would provide equivalent postoperative analgesia to ISB 30 minutes after shoulder surgery and therefore designed the current study as an equivalence trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing arthroscopic shoulder surgery
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35 kg/mt2
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Obstructive or restrictive pulmonary disease (assessed by history and physical examination)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs)
- •Pregnancy
- •Prior surgery in the neck or infraclavicular region
- •Chronic pain syndromes requiring opioid intake at home
结局指标
主要结局
Static pain 30 minutes after arrival in the post anesthesia care unit (PACU)
时间窗: 30 minutes after PACU arrival
Pain intensity at rest using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
次要结局
- Block performance time(1 hour before surgery)
- Incidence of HDP 30 minutes after PACU arrival(30 minutes after PACU arrival)
- Static pain 3 hours after arrival in the PACU(3 hours after PACU arrival)
- Static pain 12 hours after arrival in the PACU(12 hours after PACU arrival)
- Static pain 6 hours after arrival in the PACU(6 hours after PACU arrival)
- Static pain 24 hours after arrival in the PACU(24 hours after PACU arrival)
- Static pain 36 hours after arrival in the PACU(36 hours after PACU arrival)
- Static pain 48 hours after arrival in the PACU(48 hours after PACU arrival)
- Incidence of nerve block side effects(0 minutes after skin disinfection to 30 minutes after the nerve block)
- Basal diaphragmatic function(1 hour before surgery)
- Postoperative opioid related side effects(48 hours after PACU arrival)
- Static pain 1 hour after arrival in the PACU(1 hour after PACU arrival)
- Intensity of pain during block procedure(1 hour before surgery)
- Block onset time(1 hour before surgery)
- Sensory and motor block score(30 minutes after the ending time of local anesthetic injection)
- Intraoperative opioid requirements(Intraoperative period)
- Postoperative opioid consumption(48 hours after PACU arrival)
- Incidence of hemidiaphragmatic paralysis (HDP) at 30 minutes after interscalene or infraclavicular-suprascapular block(30 minutes after the ending time of local anesthetic injection)
- Patient satisfaction(24 hours after PACU arrival)
- Duration of surgery(4 hours after skin incision)
- Persistent neurologic deficit(7 days after surgery)
研究者
Julian Aliste
Associate Professor
University of Chile