Diaphragmatic Paralysis After Interscalene Brachial Plexus Block: A Randomized, Double-blinded, Unicenter and Controlled Clinical Trial to Reduce the Dose of Levobupivacaine 0,25% 20 ml to 10 ml Undergoing Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from Baseline Diaphragmatic Thickness Ratio at 4 hours
研究概览
简要总结
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
详细描述
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
The primary study objective is to determine the HDPA diagnosed by using diaphragmatic thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative harms between two trial-arms.
This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After randomization, only Interscalene Block performer staff will know which intervention group is assigned to the participants. Spirometry and ultrasound assessments will be conducted by only one blinded anesthesiologist of Assessment staff who will not be communicated to IBPB staff. Recruitment and Assessment staff and participants will not be allowed to receive any information about the group allocation. Study unblinding will occur when every ultrasound and Spirometry assessments have been completed after 24-hour follow-up postoperative closeout. After follow-up finished, every study data will figure in the patient medical record. Code breaks should occur only in exceptional circumstances when knowledge of the actual treatment is absolutely essential for further management of the patient as an allergy episode. The Research staff will be encouraged to maintain the blind as far as possible. Unblinded IBPB staff will manage the emergency.
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
- 是
入选标准
- •Patients aged 18 to 80 years.
- •ASA I-III.
- •Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.
排除标准
- •Age <18 and >80 years.
- •Pregnancy.
- •Exclusión to perform IBPB or spirometry.
- •Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs.
- •Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month).
- •Coagulation disorders (INR>3, TTPA > 35 y AP <50%).
研究组 & 干预措施
Standard Volume Dose
24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.
干预措施: Interscalene brachial plexus block (Procedure)
Standard Volume Dose
24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.
干预措施: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
Low Volume Dose
24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.
干预措施: Interscalene brachial plexus block (Procedure)
Low Volume Dose
24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.
干预措施: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
结局指标
主要结局
Change from Baseline Diaphragmatic Thickness Ratio at 4 hours
时间窗: Before (Baseline) and 4-hour after interscalene brachial plexus block
The primary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to diaphragmatic thickness ratio (DTR) in ultrasounds between the Treatment and Control groups. DTR will be the result of Inspiratory Diaphragmatic Thickness and Expiratory Diaphragmatic Thickness. The ratio will be defined by DTR=IDT/EDT. HDPA after IBPB at 4 hours will be diagnosed with a DTR\<1.2.
次要结局
- Incidence and frequency of Serious Adverse Events (SAE)(From performing the interscalene brachial plexus block to finish the 24-hour postoperative follow-up)
- Change from Baseline FEV1 at 4 hours and 24 hours(Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block)
- Change from Baseline FVC at 4 hours and 24 hours(Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block)
- Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours(Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block)
- Postoperative time to first analgesic consumption(From 4-hour to 24-hour after interscalene brachial plexus block)
- Postoperative IV morphine consumption(From 4-hour to 24-hour after interscalene brachial plexus block)