The Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery - A Double-blinded Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Analgesia time
研究概览
简要总结
Coronary artery bypass surgery (CABG), typically performed through a median sternotomy, causes significant postoperative pain. Managing this pain effectively while reducing reliance on opioids is essential, as opioids can lead to side effects such as respiratory depression, nausea, and potential for dependence. Regional anesthesia techniques like the erector spinae plane block (ESPB) have emerged as promising tools to control pain and support recovery.
This randomized, double-blind clinical trial evaluates whether adding dexmedetomidine, a sedative and analgesic, to ropivacaine, a local anesthetic, in bilateral ESPB can improve pain control after off-pump CABG surgery. The study is conducted at the Lebanese American University Medical Center - Rizk Hospital.
A total of 110 adult patients undergoing elective surgery are randomly assigned to one of two groups:
- Group R: Receives ropivacaine alone in the ESPB.
- Group RD: Receives ropivacaine with dexmedetomidine.
The nerve block is administered before anesthesia. The primary outcome is the duration of effective pain relief (pain score ≤4) before the patient needs opioid medication, assessed up to 24 hours after extubation.
Secondary outcomes include:
- Pain scores monitored for up to 48 hours post-extubation
- Total intraoperative opioid use
- Time to extubation, ambulation, and incentive spirometry use
- ICU stay duration
- Side effects such as nausea, bradycardia, or local anesthetic toxicity
This study supports efforts to reduce opioid use after heart surgery while maintaining effective pain management, aligning with enhanced recovery protocols and addressing the broader public health challenge of opioid overuse.
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)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 25 - 80 years old
- •Planned for elective OFF PUMP CABG
- •Cognitively not impaired
- •American Society of Anesthesiologists class 3
- •Left ventricular ejection fraction ≥40%
- •Consent form for the study signed
- •No infection at the site of injection
- •No contraindication for ESP block (thrombocytopenia, anticoagulation therapy)
- •No documented allergy to ropivacaine or dexmedetomidine
排除标准
- •Refusal to participate in the study
- •Emergency surgery
- •American Society of Anesthesiologists class >3
- •Left ventricular ejection fraction <40%
- •Infection at the site of injection for ultrasound-guided ESPB
- •Coagulation disorders
- •Documented allergy to ropivacaine or dexmedetomidine
- •Greater than first-degree heart block
- •Bradycardia (heart rate [HR] < 50 bpm)
- •Psychiatric illnesses that would interfere with the assessment of pain scores
- •History of alcohol or drug abuse and chronic analgesic use
研究组 & 干预措施
Group Combination Ropivacaine and Dexmedetomidine (RD)
In Group RD, patients will receive 20 ml of 0.375% ropivacaine plus 0.5 micrograms/kg of dexmedetomidine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block.
干预措施: Dexmedetomidine (Drug)
Group Ropivacaine Only (R)
In Group R, patients will receive 20 ml of 0.375% ropivacaine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Analgesia time
时间窗: From the moment the patient is awake in the Intensive Care Unit until the end of the patient's study inclusion time (48 hours after extubation)
The period during which the pain numerical rating scale score remains less than or equal to 4 and until the time the patient required the administration of opioid as the first administration. The numerical rating scale score is a 0-10 scale, where 0 represents "no pain" and 10 represents "worst pain imaginable".
次要结局
- Total amount of rescue analgesics used(Postoperatively until 48 hours post-extubation)
- Total intraoperative opioid(Intraoperatively)
- Pain score(Postoperatively until 48 hours post-extubation)
研究者
Caroline Chahine
Clinical Instructor of Medicine
Lebanese American University Medical Center