Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
研究概览
简要总结
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
详细描述
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.
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
Patients will be blinded to their treatment arm assignment, as will all research personnel who be responsible for collection of outcome data, as well as the surgeons performing the procedure, and critical care staff caring for the patients in the postoperative period. The anesthesiologist who will be performing the Pecto-intercostal Fascial Block (PIFB) will open the envelope informing them of the arm assignment; they will be the only care providers unblinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between undergoing cardiac surgery involving sternotomy
排除标准
- •Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
- •existing neurologic deficit in the chest wall;
- •remaining intubated at the six hour point after block placement
- •weight under 50kg
- •undergoing emergency surgical procedures or urgent return to the operating room
- •active endocarditis or mediastinitis
- •moderate to severe right ventricular function before or after cardiopulmonary bypass
- •reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
- •reliance on extracorporeal membrane oxygenation
- •localized or systemic infection
- •chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
- •those who are pregnant
研究组 & 干预措施
Pecto-intercostal Fascial Block (PIFB)
Subjects in this arm receive standard of care PIFB after surgery
干预措施: Pecto-intercostal Fascial Block (PIFB) (Drug)
PIFB with adjuvants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
干预措施: PIFB with adjuvants (Drug)
结局指标
主要结局
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
时间窗: 36 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
次要结局
- Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest(6, 12, 18, 24 hours after block placement)
- Average Cumulative Opioid Consumption(36 hours after block placement)
- Average Time to First Opioid Administration(Up to 36 hours after block placement)
- Incentive Spirometry Volumes(6, 12, 18, 24 hours after block placement)
- Safety Outcome: Nausea Incidence(Up to 36 hours after block placement)
- Average Time to Extubation(Up to 36 hours after block placement)
- Duration of Intensive Care Unit (ICU) Admission(Up to 52 hours after block placement)
- Safety Outcome: Vomiting Incidence(Up to 36 hours after block placement)
- Safety Outcome: Postoperative Delirium Incidence(Up to 36 hours after block placement)
- Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen(36 hours after block placement)