Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption 72 Hours Post-operatively
研究概览
简要总结
This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.
详细描述
Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.
The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).
This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).
The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.
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, Care Provider)
盲法说明
Each study participant and OR anesthesia team, cardiac surgery team, cardiothoracic ICU team, and nursing staff caring for the participant will be blinded to the study drug the patient received. However, the anesthesia provider performing the block (separate from the provider caring for the patient in the operating room) will not be blinded to the study drug injected and will have access to all monitors deemed appropriate by the primary team caring for the participant.
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
- •Participant provides consent to participate in study
- •Ideal body weight (IBW) is >50kg
- •Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
- •Participant is undergoing an elective procedure
排除标准
- •Participant is unable or unwilling to give consent
- •Non-English speaking
- •Known or believed to be pregnant or is currently breastfeeding
- •Participant is a prisoner
- •Clinically unstable per discretion of the Investigator
- •Participant requires urgent/emergent surgery
- •History of previous sternotomy
- •Preoperative coagulopathy (INR >1.4, platelets <100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg)
- •Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine
- •Participant has decompensated heart failure
- •Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe")
- •Diagnosis of cirrhosis or end-stage liver disease
- •Requires the use of mechanical circulatory support pre-operatively
- •Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)
研究组 & 干预措施
PIFB intervention
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
干预措施: Bupivacaine Injection (Drug)
PIFB intervention
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
干预措施: Liposomal bupivacaine (Drug)
Saline Control
bilateral PIFB with 25 mL saline only
干预措施: Saline (Other)
结局指标
主要结局
Total Opioid Consumption 72 Hours Post-operatively
时间窗: up to 72 hours post-operatively
Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
次要结局
- Total Intraoperative Opioid Consumption(intraoperative period ranging from anesthesia start time to anesthesia end time)
- Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op(data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively)
- Maximum Pain Scores up to 72 Hours Postoperatively(up to 72 hours post-op)
- Pain Score at 90 Days Postoperatively(up to 90 days post-op)
- Daily Opioid Consumption up to 72 Hours Postoperatively(up to 72 hours post-op)
- Hours of Mechanical Ventilation After ICU Admission(up to 72 hours post-op)
- Number of Postoperative Days Until the First Bowel Movement(up to 72 hours post-op)
- Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)(up to 72 hours post-op)
- Number of Hours That the Patient is in the ICU(up to 72 hours post-op)
- Number of Post-operative Days Until the Patient is Discharged(Up to 7 days)
- Count of Participants Using Opioids at 90 Days Postoperatively(up to 90 days post-op)