Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hemidiaphragmatic paralysis before discharge
研究概览
简要总结
Interscalene brachial plexus block (ISB) constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery.
The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •body mass index between 20 and 35
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)
- •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 ipsilateral neck region
- •chronic pain conditions
结局指标
主要结局
Hemidiaphragmatic paralysis before discharge
时间窗: 24 hours after surgery
Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography
次要结局
- Amount of local anesthetic (LA) boluses used before discharge.(24 hours after surgery)
- Level of static pain 12 hours after arrival to PACU(12 hour after arrival to PACU)
- Hemidiaphragmatic paralysis after surgery(30 minutes after arrival to post anesthetic care unit (PACU))
- Level of static postoperative pain at 30 minutes of arrival to PACU(30 minutes after arrival to PACU)
- Level of static postoperative pain 3 hour after arrival to PACU(3 hours after arrival to PACU)
- level of static pain 6 hours after arrival to PACU(6 hours after arrival to PACU)
- postoperative morphine equivalent consumption(24 hours after surgery)
- Incidence of side effects before discharge(24 hours after surgery)
- incidence of side effects after discharge with ambulatory continuous ISB.(24 to 72 hours after surgery)
- Level of static postoperative pain 1 hour after arrival to PACU(60 minutes after arrival)
- Level of static pain before discharge(24 hours post surgery)
- Level of static pain during first day after the day of discharge(48 hours after surgery)
- Motor block in PACU(30 minutes after arrival to PACU)
- sensory block previous to discharge(24 hours after surgery)
- motor block previous to discharge(24 hours after surgery)
- intraoperative morphine equivalent consumption(intraoperative period)
- Level of static pain during second day after the day of discharge(72 hours after surgery)
- sensory block in PACU(30 minutes after arrival to PACU)
研究者
Julián Aliste
Anesthesiololgist, Clinical Instructor
Clinica las Condes, Chile