跳至主要内容
临床试验/NCT05090735
NCT05090735Unknown不适用

Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Transversus Abdominis Plane (TAP) Block More Helpful Than SPIP Blocks Alone in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?

Wayne State University0 个研究点目标入组 100 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Visual analog scale (VAS) pain scores

研究概览

简要总结

The purpose of this study is to determine whether superficial parasternal intercostal plane (SPIP) block alone or with transverses abdominis plane (TAP) block 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
Double (Participant, 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
否

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

Active Comparator

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: SPIP Block (Procedure)

SPIP Block with TAP Block

Active Comparator

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. This group of patients will also receive unilateral TAP block by injecting 20 mL of 0.25% bupivacaine in the plane between the internal oblique and transversus abdominis muscles.

干预措施: SPIP and TAP Block (Procedure)

结局指标

主要结局

Visual analog scale (VAS) pain 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

Post-operative total opioid consumption (oral morphine equivalents)

时间窗: 24 hours after surgery

Total Opioid consumption 24 hours post surgery oral moral morphine equivalents

Visual analog scale (VAS) pain scores

时间窗: 6 hours after surgery

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

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)

次要结局

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

研究者

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

Sandeep Krishnan

Associate Professor of Anesthesiology

Wayne State University

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