Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Morphine consumption in the first 24 hours after surgery
研究概览
简要总结
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.
详细描述
It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries.
The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy.
Patients will be divided into two groups:
Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.
Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients randomly will be classified into two groups using opaque sealed envelopes. Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group is placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group written in the envelope. An anesthesiologist with expertise in regional anesthesia will perform PIF and TTP block to ensure the block's quality and consistency.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
- •BMI <35 kg / m2
排除标准
- •Emergent surgeries, redo cases, minimally invasive procedures
- •Patients who do not want to participate
- •Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
- •Hypersensitivity or history of allergies to local anesthetics
- •Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
- •LVEF <30
- •Patients with psychiatric disorders
- •Pregnancy or breastfeeding
- •Presence of hematological disease
- •Patients with alcohol-drug addiction
- •Patients who use daily opioids for any reason
结局指标
主要结局
Morphine consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.
次要结局
- Postoperative pain: NRS score(Postoperative Day 1)
- Length of stay in the hospital(Measured in days admitted in the hospital, an average of 7 days)
- The number of patients with complications(Postoperative 7 days on an average)
- Postoperative nausea and vomiting (PONV)(Postoperative Day 1)
- Patient satisfaction(Postoperative Day 1)
- The number of patient required rescue analgesic(Postoperative Day 1)
- Time to extubation(Postoperative Day 1)
- Length of stay in the ICU(The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days)
研究者
Cengiz KAYA
Associate Professor
Ondokuz Mayıs University