Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block
研究概览
简要总结
This clinical trial is for subjects undergoing right upper extremity surgery. The aim of the study is to investigate the dose-response relationship between local anesthetic volume and ipsilateral hemidiaphragmatic paresis (HDP) in patients getting ultrasound-guided supraclavicular brachial plexus blocks in a blinded, prospective trial.
详细描述
With traditional landmark-based or nerve-stimulator techniques, the incidence of HDP following supraclavicular blocks is approximately 50-67%. Ultrasound-guided techniques are thought to enhance precision while reducing the volume of anesthetic used, but even then HDP incidence is nearly 60%. To date, no trials have studied the dose-response relationship between local anesthetic volume and degree of HDP.
Patient Selection
30 eligible patients undergoing right upper extremity surgery and eligible for supraclavicular blocks will be recruited at NewYork-Presbyterian/Weill Cornell Medical Center.
Evaluation of HDP
Baseline M-mode recordings of diaphragm function will be made by an anesthesiologist. Patients will perform "voluntary sniff" (VS) tests, or forceful nasal inhales, immediately preceding the brachial plexus blockade, and again at 15 minutes and 30 minutes after the block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The physician reviewing the ultrasound images and determining the presence/absence of diaphragm paralysis is masked to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing right upper extremity surgery with supraclavicular block as the primary anesthetic
- •Age greater than or equal to 18 years of age
- •American Society of Anesthesiologists (ASA) physical status 1 to 3
- •Able to give informed consent
排除标准
- •Patient refusal for supraclavicular block
- •Inability to give informed consent
- •Allergy to local anesthetics
- •Hemidiaphragmatic dysfunction, suspected or known pulmonary disease
- •Neuromuscular disease
- •Obstructive or restrictive pulmonary disease
- •Medical or anatomic contraindication to supraclavicular blockade as judged by clinician
- •Pregnancy
研究组 & 干预措施
Dose Cohort 7
5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 7
5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 7
5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 6
10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 6
10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 6
10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 5
15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 5
15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 5
15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 4
20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 4
20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 4
20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 3
Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 3
Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 3
Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 2
30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 2
30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 2
30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
Dose Cohort 1
35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Ultrasound Imaging (Diagnostic Test)
Dose Cohort 1
35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Supraclavicular Block (Drug)
Dose Cohort 1
35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
干预措施: Bedside Negative Inspiratory Force Meter (Other)
结局指标
主要结局
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block
时间窗: 15 minutes
Diaphragm motion was recorded during voluntary sniffing fifteen minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block
时间窗: 30 minutes
Diaphragm motion was recorded during voluntary sniffing 30 minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
次要结局
- Subjective Dyspnea 30 Minutes After Block(30 minutes)
- Change in Negative Inspiratory Force (NIF) at 30 Minutes(30 minutes)
- Dose Response Curve for Motor and Sensory Block 15 Minutes After Block(15 minutes)
- Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block(30 minutes)
- Change in Room Air Oxygen Saturation at 30 Minutes.(30 minutes)