A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Static Pain using numeric scale 0-10
研究概览
简要总结
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease.
This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.
Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.
详细描述
PATIENT RECRUITMENT
With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40 patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be carried out by an investigator not involved in patient care. Patients' confidentiality will be protected.
STUDY PROTOCOL: GENERAL
All blocks will be performed by one of the coauthors and conducted preoperatively in an induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient comfort.
STUDY PROTOCOL: PERFORMANCE OF THE BLOCK
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years
- •American Society of Anesthesiologists classification 1-3
- •body mass index between 20 and 30
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, infraclavicular region or suprascapular fossa
- •chronic pain syndromes requiring opioid intake at home
结局指标
主要结局
Static Pain using numeric scale 0-10
时间窗: 30 minutes after arrival to PACU
次要结局
- Static Pain using numeric scale 0-10(24 hrs)
- Diaphragm paralysis incidence(30 minutes after block)
研究者
Julian Aliste
MD Clinical Instructor
University of Chile