Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block for Fast Tracking and Postoperative Analgesia in Open Heart Surgery Through Midline Sternotomy. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- pain assessment will be done using VAS scoring system
研究概览
简要总结
In 2012 Blanco et al. [1] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries.
PECS block includes PECS I and PECS II (modified PECS I) interfascial blocks. Since that time, PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies, breast-conserving surgeries, breast implant placement, automated implantable cardioverter-defibrillator (AICD)/pacemaker placement, intercostal drainage tube placement, and rib fractures. In this study, the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine.
详细描述
This study will be performed at the FAYOUM University Hospital after approval from the local Institutional Ethics Committee and the local Institutional Review Board. It will be a double-blind randomized controlled study. The eligible patients will sign a detailed informed consent form before recruitment and randomization.
After confirming hemodynamic stability, satisfactory blood gasses, electrolytes, normalized activated coagulation time (ACT < 120 s), and minimal drain output, bilateral PECS block will be performed guided by a linear ultrasound transducer (12 MHz). 5
The block will be performed in a supine position with the arm slightly abducted. Under complete aseptic precautions, and using a 20 gauge 5 cm needle. The ultrasound probe will be placed at the midclavicular level inferolaterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib.
The needle will be inserted in the plane concerning the ultrasound probe. A volume of 20 ml of local anesthetic solution will be deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between pectoralis major and pectoralis minor muscle, where a volume of 10 ml will be deposited. The block will be performed similarly on both sides. It will be noted that the total dose of local anesthetic is not to exceed the toxic dose of ropivacaine (3 mg/kg). Patients then will be transferred intubated to the Surgical ICU (SICU), and standard monitoring will be continued until patients are fully awake, patients will be extubated once they fulfilled the extubation criteria.
Sample Size ( number of participants included ) 90 patients
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 - 65 years,
- •Ejection fraction (EF) > 35%,
- •Elective isolated CABG, or Valve surgery
排除标准
- •Poor left ventricular function with intra-aortic balloon pump support,
- •Recent myocardial infarction (last seven days),
- •Combined procedure (i.e., CABG + other heart/vascular procedure),
- •Emergency surgery, or Redo cases,
- •Hepatic or renal failure, creatinine >1.5,
- •Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.
研究组 & 干预措施
Group (R)
will receive 30 ml of 0.25% of plain ropivacaine for each side.
干预措施: ropivacaine (Drug)
Group (C)
the control group will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.
干预措施: fentanyl (Drug)
Group (DR)
will receive 30 ml of 0.25% ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
干预措施: ropivacaine (Drug)
Group (DR)
will receive 30 ml of 0.25% ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
pain assessment will be done using VAS scoring system
时间窗: The first 24 hours postoperative
(In a pain scale \[0-10\] at rest and during cough by an intensivist blinded to the study groups at 0 h (at extubation) and thereafter at 3, 6, 12, 18, and 24 h intervals. Pain will be classified into mild, moderate, and severe for analysis (mild VAS 0-4, moderate VAS 5-7, and severe VAS \>8)
Total opioid consumption
时间窗: from the time of ICU admission hour 1 up to hour 24
the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU
次要结局
未报告次要终点
研究者
Mohamed Ahmed Hamed
Associate Professor
Fayoum University