Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- OPIOID consumption during surgery
研究概览
简要总结
The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia [MMA]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block [PIFB]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.
详细描述
Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.
Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.
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
- Double (Participant, Outcomes Assessor)
盲法说明
PIFB will be administered to the patient after anesthesia induction and before surgical incision according to the randomization regimen. The unblinded researcher will randomize and inform to the unblinded anesthesia care provider who will perform the PIFB procedure. The rest of clinicians, research personnel and patients will be blinded to the group assignment.
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 male or female patients aged > 18
- •Undergoing primary cardiac surgery requiring sternotomy
- •Able to provide a signed written informed consent
- •Able to speak, read, and write in English
- •American Society of Anesthesiologists (ASA) physical status I-IV
排除标准
- •Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
- •Diabetes Mellitus with documented neuropathic pain
- •Vulnerable populations: pregnant females, prisoners, breast feeding
- •Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
- •Previous cardiac surgery
- •Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
- •Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
- •BMI ≥ 40 kg/m2
研究组 & 干预措施
Pecto-intercostal fascial block
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.
干预措施: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine (Procedure)
Placebo
Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.
干预措施: Pecto-intercostal Fascial Block with normal saline (Procedure)
结局指标
主要结局
OPIOID consumption during surgery
时间窗: Surgery length
To compare the amount of opioid consumption oral MME consumption during surgery between groups
OPIOID consumption at 24 hours
时间窗: 24 hours after block procedure
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
Worst pain score at 48 hours
时间窗: Up to 48 hours after block procedure
To compare the worst pain experienced during up to 48-hours after surgery between groups
Incidence nausea and/or vomiting after surgery
时间窗: Up to 48 hours after block procedure
To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
Self-reported satisfaction score at 48 hours
时间窗: 48 hours after block procedure
To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
NRS pain score at 48 hours
时间窗: Up to 48 hours after block procedure
To compare the NRS (0-10) pain score up to 48 hours
pain-DETECT scores at 90 days
时间窗: Up to 90 days after block procedure
To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups
次要结局
未报告次要终点
研究者
Erica Stein
Professor
Ohio State University