IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
研究概览
简要总结
Interfascial plane blocks have been developed for analgesia, among which the erector spinae plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal analgesia by spread of local anesthetic into the paravertebral space. Recent studies have contested this idea showing unreliability in the spread of the local anesthetic into the paravertebral space.
详细描述
Post-operative pain is a significant issue following open heart surgeries and poorly controlled pain can result in significant cardiorespiratory morbidity. Many patients suffer pain both at rest (49%) and on movement (62%) following open heart surgeries via sternotomy and adequate pain management requires closer re-assessment and treatment. The intensity of pain is noted to be higher in the first 48 hours post surgery and hence modalities to control pain may make the greatest difference in the first 2 days after surgery.
Enhanced recovery pathways utilizing multimodal analgesia have shown significant analgesic and opioid sparing benefit while minimizing ICU and length of hospital stays. Some multimodal regimens have also incorporated regional blocks but the optimal analgesic regimen remains elusive. The ESP block has been hypothesized to provide truncal anesthesia by spread of local anesthetic into the paravertebral space, but recent studies contest this idea. Bilateral paravertebral blocks can result in higher than acceptable levels of local anesthetic in both cardiac and non-cardiac surgical patients and this may be true following bilateral erector spinae plane (ESP) as well. Hence, the pharmacokinetic profile of administered local anesthetics is necessary given the lack of information about the local anesthetic systemic levels following bilateral ESP.
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
- None (Participant, Outcomes Assessor)
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
- •Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy.
- •English speaking
排除标准
- •Emergency surgery
- •Allergy to medications (ie lidocaine)
- •BMI less than 20 or greater than 50
- •Major liver or kidney dysfunction or other pre-existing major organ dysfunction
- •Revision cardiac surgery
- •Surgery via thoracotomy
- •Off-pump coronary artery bypass
- •Narcotic dependent (Opioid intake morphine equivalents greater than 10mg/day for more than 3 months
- •Chronic pain (ie fibromyalgia)
- •Significant central nervous system or respiratory disease
- •Hematological disorders or de-ranged coagulation parameters
- •Psychiatric illness that impedes subject from providing informed consent
- •Pre-operative neurological deficits
- •Language barrier
- •Inability to provide informed consent
- •Prisoner status
- •Pregnancy
研究组 & 干预措施
Erector Spinae Plane Block-Administration of Lidocaine
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
干预措施: Administration of Lidocaine Post Cardiac Surgery via ESP Catheter (Drug)
Intravenous-Administration of Lidocaine
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
干预措施: Intravenous Administration of Lidocaine Post Cardiac Surgery (Drug)
结局指标
主要结局
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
时间窗: 48 hours post surgical intervention
To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. Cumulative opioid usage amounts required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Compare Pain Score Reported by Subject 48 Hours Postoperatively
时间窗: 48 hours post surgical intervention
Using a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as median and interquartile range.
次要结局
- Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention(First 24 hours post surgical intervention)
- Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention(From 24 to 48 hours post surgical intervention)
- Pain Score at 24 Hours Postoperatively(24 hours post surgical intervention)
- Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.(24 hours post intervention)
研究者
Archit Sharma
Clinical Associate Professor
University of Iowa