A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Total Cumulative Opioid Consumption
研究概览
简要总结
The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
详细描述
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group.
Primary Outcomes:
Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.
Total cumulative opioid consumption at 24 and 48 hours post-operatively.
Secondary Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
- •Age 18-85 years of age
- •BMI 18-50 kg/m2
- •Weight > 60 kg
排除标准
- •Left ventricular ejection fraction (LVEF) < 30%
- •Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
- •Inability to understand or speak English
- •Allergy to bupivacaine or other amide local anesthetic
- •Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
- •Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three months
- •Severe pulmonary or hepatic disease
- •Neurological deficit or disorder
- •Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
- •Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
研究组 & 干预措施
Rectus sheath block block with PIFB (experimental arm)
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
干预措施: Rectus sheath block with bupivacaine (Drug)
Rectus sheath block with PIFB (placebo arm)
PIFB with local anesthetic with RSB placebo (saline)
干预措施: Rectus sheath block with bupivacaine (Drug)
结局指标
主要结局
Total Cumulative Opioid Consumption
时间窗: 48 hours post-operatively
Total cumulative opioid consumption at 48 hours
Pain Scores at Rest Within the First 24 Hours After Extubation
时间窗: 24 hours after extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation
时间窗: 24 hours after extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
次要结局
- Vital Capacity Change From Baseline on Incentive Spirometry(24 hours post-extubation)
- Time From ICU Arrival to Liberation From Mechanical Ventilation(ICU arrival until extubation)
- Hospital Length of Stay(Time from anesthesia stop to hospital discharge, typically one week)
- QoR-15 (Quality of Recovery) Score(24 hours after extubation)
- ICU Length of Stay(Time from anesthesia stop to transfer out of ICU, typically 24 hours)
研究者
Anne Castro, MD
Assistant Professor of Anesthesiology
Medical College of Wisconsin