Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Opioid Consumption POD 1
研究概览
简要总结
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
详细描述
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The only people who will know the treatment arm that has been assigned to the participant are the research coordinator who randomized them and the regional anesthesia team. The patient, nursing team, and research coordinator performing outcomes assessments will all be blinded to the treatment group.
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
- •Non-emergent elective cardiac surgery requiring median sternotomy for surgical exposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESP catheter preoperatively
- •Age 18-90
排除标准
- •Placement and/or existence of cardiac assist devices (LVAD, RVAD, Balloon Pump, Impella)
- •Neurocognitive dysfunction
- •Patients who expire before extubation
- •Non-English speaking
- •Daily opioid therapy prior to surgery
- •History of substance abuse
- •BMI > 45
研究组 & 干预措施
Continuous Infusion
Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.
干预措施: Continuous Infusion of ropivacaine (Drug)
Intermittent Bolus
Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.
干预措施: Intermittent bolus of ropivacaine (Drug)
结局指标
主要结局
Opioid Consumption POD 1
时间窗: 0-24 hours post-op
Opioid consumption (MME) over the course of the first 24 hours following surgery
Opioid Consumption POD 2
时间窗: 24-48 hours post-op
Opioid consumption (MME) over the course of the 48 hours following surgery
Opioid Consumption POD 3
时间窗: 48-72 hours post-op
Opioid consumption (MME) over the course of the 48-72 hours following surgery
次要结局
- Quality of Recovery 15 (QoR-15) Score POD 2(24-48 hours post-op)
- NRS Pain Score POD 1(0-24 hrs post-op)
- NRS Pain Score POD 2(24-48 hrs post-op)
- NRS Pain Score POD 3(48-72 hrs post-op)
- ICU Length of Stay(7 days post-op)
- Quality of Recovery 15 (QoR-15) Score POD 1(0-24 hours post-op)
- Quality of Recovery 15 (QoR-15) Score POD 3(48-72 hours post-op)
- Time to First Antiemetic(0-200 hours post-op)
- Time to First Bowel Movement(0-72 hours post-op)
研究者
Patrick Forrest
Principal Investigator
Henry Ford Health System