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临床试验/NCT04788056
NCT04788056撤回不适用

Parasternal Subpectoral Plane Blocks for Patients Undergoing Cardiac Surgery Involving Median Sternotomy - a Study of Opioid and Pain Reduction

Brigham and Women's Hospital0 个研究点目标入组 154 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
154
主要终点
Opioid Consumption

研究概览

简要总结

To better determine whether parasternal subpectoral plane blocks (PSPB) infusing bupivacaine for midline sternotomy decreases opioid consumption and pain scores.

This is a prospective, blinded randomized controlled trial with 2 arms. 1 arm is the saline control arm, PSPB catheters will be placed with saline and continue to infuse saline. The other arm is bupivacaine study arm, PSPB catheters will be placed with bupivacaine and continue to infuse the local anesthetic.

详细描述

Subjects will be randomized to receive PSPB catheters infusing either bupivacaine or saline. Randomization will be achieved using a computer-generated randomization scheme. The surgeon, nurse, anesthetist and patient will be blinded. The investigational drug service will prepare blinded solutions (bupivacaine 0.2% or saline syringes) for performance of the block. They will also prepare bags (either bupivacaine 0.125% or saline) to be infused through the catheter.

Following skin closure, but before removal of the surgical drapes, regional anesthesiologists will scrub in, gown and perform the placement of PSPB catheters under strict surgical aseptic technique. Real-time ultrasound (US) imaging will be used to visualize the pectoralis major muscle and its corresponding rib cartilages, and a needle/introducer sheath will be guided parasternally into the fascial plane. The needle will be advanced in the plane, hydro-dissecting with 30 mL of bupivacaine 0.2% in the study group or 30 mL of saline in the control group per side. Following hydro-dissection, a 5 in. multiport catheter will be inserted via the sheath, and the catheter will be secured following US confirmation of appropriate catheter position. This procedure will then be repeated on the other side. After completion of bilateral PSPB catheters, patients will remain intubated and be transferred to the CSICU on a sedation regimen at the discretion of the intraoperative anesthesia team. Upon dropping off to the ICU, each catheter will be attached to a programmable pump infusing plain bupivacaine 0.125% at 10 mL/hr or saline infusing at 10 mL/hr. Once again, the solution to be infused postoperatively will be prepared by pharmacy and blinded from the patient, nurse, and postoperative pain service providers.

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)

盲法说明

Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.

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

入选标准

  • Male or Female
  • Aged 18 - 80 years
  • scheduled for primary elective cardiac surgery via median sternotomy
  • willingness to undergo psychosocial testing
  • willingness to participate in long-term follow up
  • willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters
  • access to an email and computer

排除标准

  • Allergy to opioids
  • allergy to bupivacaine
  • emergency surgery
  • unable to provide informed consent
  • weight less than 50kg

结局指标

主要结局

Opioid Consumption

时间窗: 2 days

Cumulative opioid consumption on post-operative day 1 and 2

次要结局

  • Persistent Postoperative Pain scores(Measured at 1 year)
  • Incidence of arrhythmia(Hospital stay, an average of 5 days)
  • Length of ICU stay(From arrival to ICU to discharge to floor, up to 5 days)
  • Time to extubation(Post-operative day 1)
  • Acute Postoperative Pain scores(through initial hospital stay, an average of 5 days)
  • Pain and patient characteristics(1 year)
  • Length of hospital stay(From arrival to ICU to discharge from hospital, up to 5 days)
  • Incidence of delirium(Time in ICU to discharge to floor, up to 3 days)
  • Time to first opioid administration after extubation(Extubation to first opioid administration, up to 3 days)

研究者

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

Kamen Vlassakov

Director of Regional Anesthesia

Brigham and Women's Hospital

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