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临床试验/NCT05003765
NCT05003765Unknown不适用

Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Local Anesthetic Alone and Local Anesthetic With Adjuvants Helpful in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?

Wayne State University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Post-operative total opioid consumption (oral morphine equivalents)

研究概览

简要总结

The purpose of this study is to determine whether the addition of the superficial parasternal intercostal plane (SPIP) block alone (30cc of 0.25% bupivacaine) or plus Magnesium (200mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300mcg) as adjuvants can improve post-operative pain in patients undergoing cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG)

详细描述

Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control can have adverse pathophysiologic consequences, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for formation of clots in a blood vessels (thromboembolism). These adverse events may result in greater perioperative morbidity and mortality. Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains an issue.

Regional anesthesia is used to block sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.

Ultrasound has revolutionized regional anesthesia by allowing real-time visualization of anatomical structures, needle advancement and local anesthetic (LA) spread. This has led not only to refinement of existing techniques, but also the introduction of new ones.

In particular, ultrasound has been critical in the development of fascial plane blocks, in which local anesthetic (LA) is injected into a tissue plane rather than directly around nerves. These blocks are believed to work via passive spread of LA to nerves traveling within that tissue plane, or to adjacent tissue compartments containing nerves.

Although research into these techniques is still at an early stage, the available evidence indicates that they are effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics, rather than as sole anesthetic techniques. Catheters may be beneficial in situations where moderate-severe pain is expected for >12 hours, although the optimal dosing regimen requires further investigation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary coronary artery bypass grafting

排除标准

  • Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.)
  • Patients with significant platelet dysfunction
  • Infection at site for regional anesthesia
  • Allergy to local anesthetics
  • Severe aortic stenosis
  • Severe mitral stenosis

研究组 & 干预措施

SPIP Block

Experimental

Arm 2-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

SPIP Block + Magnesium

Experimental

Arm 3-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine + 200mg of magnesium sulfate (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.

干预措施: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg (Drug)

SPIP Block + Magnesium + Buprenorphine

Experimental

Arm 4-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine+ 200mg of magnesium sulfate + buprenorphine (300mcg) (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.

干预措施: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg (Drug)

结局指标

主要结局

Post-operative total opioid consumption (oral morphine equivalents)

时间窗: 24 hours after the surgery

Total Opioid consumption 24 hours post surgery oral moral morphine equivalents

Visual analog scale (VAS) pain scores

时间窗: 12 hours after surgery

Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

Visual analog pain (VAS) scores

时间窗: 24 hours after surgery

Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)

Length of hospital stay (LOS)

时间窗: Up to 1 month

The days spent in the hospital from surgery to discharge

次要结局

  • Incidence of post-operation nausea and vomiting (PONV)(24 hours)
  • Acetaminophen consumption(24 hours)
  • NSAID (ketorolac) consumption(24 hours after surgery)
  • Length of ICU stay(Up to 1 month)
  • Time to extubation(24 Hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandeep Krishnan

Clinical Associate Professor of Anesthesiology

Wayne State University

研究点 (1)

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