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临床试验/NCT05589363
NCT05589363撤回4 期

A Comparison of the Analgesic Effects of Rectus Sheath and Transversus Thoracis Plane Blocks (ABC Blocks) Versus Saline Injection for Median Sternotomy: a Prospective, Randomized Controlled Trial.

Duke University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
入组人数
50
试验地点
1
主要终点
Cumulative opioid consumption from extubation to 24 hours post-extubation

研究概览

简要总结

This randomized blinded trial aims to evaluate the effect of parasternal intercostal and rectus sheath blocks ("anterior blocks for cardiac surgery" or ABC blocks) on postoperative recovery in patients undergoing median sternotomy for cardiac surgery. Subjects will be randomized to receive either local anesthetic (liposomal bupivacaine plus bupivacaine 0.25%) or saline sham block.

详细描述

Subjects will be randomized on the morning of surgery to receive either "anterior blocks for cardiac surgery" or "ABC blocks" using 60 mL of local anesthetic mixture (20 mL of liposomal bupivacaine plus 40 mL of 0.25% bupivacaine) or a sham saline ABC block (60 mL). All subjects will receive standard of care anesthetic regimen for their cardiac surgery at the discretion of his/her attending anesthesiologist. 40 mL of the solution will be administered in the parasternal intercostal space, and 20 mL will be placed in the rectus sheath in the epigastric region.

For the parasternal blocks, a linear high frequency ultrasound probe will be placed parasagitally at the T2-3 level approximately 3cm lateral to the mid-sternum, and all relevant structures will be identified, including the pectoralis major muscle, internal intercostal muscle, ribs, pleura, and any vasculature, including the internal mammary artery and vein. Color Doppler will be used confirm the location of vasculature.

After skin local anesthetic infiltration, a 10 cm 21G insulated block needle (Sonoplex, Pajunk Medical Systems, Norcross, GA) will be inserted from the inferior aspect of the ultrasound probe in a caudal to cranial direction and aligned with the ultrasound scanning plane (in-plane approach). In this way, both the needle shaft and tip can be visualized as the needle approaches the plane between the pectus major and intercostal muscles. The needle will be redirected as needed. Once satisfactory position of the needle time is confirmed and after frequent negative aspiration, 10 mL of study solution will be slowly injected. This injection will be repeated at the T4-5 interspace. Spread of local anesthetic will be documented in the appropriate plane in real time. This procedure will be performed bilaterally.

For the rectus sheath blocks, a linear high frequency ultrasound probe will be placed in a transverse position in the midline, just inferior to the xiphoid process. The probe will be moved laterally to visualize the lateral edge of the rectus abdominis muscle. A 10 cm 21G insulated block needle will be inserted from the lateral aspect of the ultrasound probe in a lateral to medial direction until visualized deep to the muscle immediately adjacent to the posterior rectus sheath. After negative aspiration, 10 mL of study solution will be slowly injected into this plane. This procedure will then be repeated on the contralateral side

All nerve blocks will be performed by a trainee supervised by an anesthesiologist experienced in regional anesthesia. The anesthesiology team and in the OR will be blinded to group allocation.

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
Single (Participant)

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

入选标准

  • Subjects scheduled for elective cardiac surgery involving primary median sternotomy
  • Age 18-85 years of age
  • BMI 18-50 kg/m2

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 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 disease
  • Neurological deficit or disorder
  • Suspected or known addition 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

ABC block with bupivacaine and liposomal bupivacaine

Active Comparator

The study solution used in the active arm will comprise 20 mL of liposomal bupivacaine (266 mg) admixed with 40 mL of 0.25% bupivacaine HCl. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

干预措施: ABC block with bupivacaine/liposomal bupivacaine (Drug)

ABC block with saline

Sham Comparator

The study solution used in the active arm will comprise 60 mL of 0.9% saline. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

干预措施: ABC block with saline (Drug)

结局指标

主要结局

Cumulative opioid consumption from extubation to 24 hours post-extubation

时间窗: Extubation to 24 hr post-extubation

Morphine equivalents administered between extubation and 24 hours post-extubation

次要结局

  • Worst pain at rest at 6 hours post-extubation(6 hours post-extubation)
  • Time from end of case to tracheal extubation(End of operative case until patient extubated, up to 24 hours)
  • ICU length of stay(Postoperative from admission to ICU to discharge to floor, approximately 3 days)
  • Worst pain at rest at 24 hours post-extubation(24 hours post-extubation)
  • Cumulative opioid consumption from extubation to 48 hours post-extubation(Extubation to 48 hr post-extubation)
  • Worst pain at rest at 2 hours post-extubation(2 hours post-extubation)
  • Worst pain at rest at 48 hours post-extubation(48 hours post-extubation)
  • Time to first session of physical therapy (PT)(0-48 hours after surgical procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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