Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 5
- 主要终点
- Cumulative postoperative opioid use up to 72 hours
研究概览
简要总结
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy.
Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
详细描述
This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:
- The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
Secondary outcomes will be: 2. cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME 3. median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion 4. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.
5.) Quality of Recovery -15 (QoR-15) score 24-96 hours post-surgery
Tertiary outcomes will be:
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
The patient, intervention appliers (i.e. the operating room staff), medical practitioners, and outcome assessors will all be blinded to the randomized treatment arm until the database is locked. Unblinding procedures will be made available for breaking codes if necessary for clinical treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing cardiac surgery via median sternotomy
排除标准
- •Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
- •Emergency procedures (surgery within 2 hours)
- •Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
- •Weight < 50kg
- •Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
- •Surgery for infective endocarditis
- •Pregnancy or nursing
- •Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
- •Allergies to amide anesthetic agents or any components of study interventions
- •Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.)
- •Receipt of an investigational drug or device within past 7 days
研究组 & 干预措施
0.2% ropivacaine
Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side after catheter placement, followed by intermittent boluses of 5 mL 0.2% ropivacaine per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
干预措施: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental (Procedure)
0.9% saline
Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of placebo(0.9% saline) per side after catheter placement, followed by intermittent boluses of 5 mL placebo(0.9% saline) per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
干预措施: Intermittent Superficial Parasternal Intercostal Plane Block - Placebo (Procedure)
结局指标
主要结局
Cumulative postoperative opioid use up to 72 hours
时间窗: 72 hours after catheter insertion.
Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours.
次要结局
- Median pain score(over 72 hours post-extubation)
- Cumulative post-operative opioid use(from time of catheter insertion until discharge from hospital)
- Delirium(for 72 hours following catheter insertion)
- Quality of Recovery-15 Scale(24-96 hours post surgery)
- Cumulative post-operative opioid use(Average of 5 days.)