Pecto-Intercostal Fascial Plane Block-Based Multimodal Analgesia to Improve Quality of Recovery After Median Sternotomy: A Randomized Non-Inferiority Trial Comparing Retro-Intercostal Fascial Plane Block and Rectus Sheath Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Turkish version of the Quality of Recovery-15 scale (QoR-15T)
研究概览
简要总结
In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB will accelerate recovery. Additionally, it is anticipated that RIFB, an alternative fascial plane block, will demonstrate non-inferior (at least as effective as) performance compared to RSB, thereby providing flexibility and ease of application in clinical practice.
详细描述
Advances in anesthesiology throughout the first quarter of the 21st century have significantly enhanced perioperative care quality and mitigated complication risks. In particular, ultrasound (US)-guided fascial plane blocks have become prominent and widely preferred methods for providing postoperative pain control in current practice. Today, fascial plane blocks form the cornerstone of multimodal analgesia strategies developed to avoid complications associated with neuraxial analgesia methods.
Thoracic fascial plane blocks (TFB) have become one of the revolutionary advancements in cardiac anesthesia practice and have been widely adopted in cardiac surgery patients.
The pectointercostal fascial plane block (PIFB), a type of TFB, was first described by De la Torre et al. in patients undergoing breast surgery. This new technique involves blocking the anterior cutaneous branches of the T2-6 intercostal nerves, which are responsible for sensory innervation of the sternal region.
PIFB is an effective method for controlling sternotomy pain in patients undergoing open-heart surgery. The technique offers several advantages, including its minimally invasive nature, its proximity to the sternotomy line, and the flexibility to be administered at any perioperative time point following anesthesia induction without requiring the patient to change position. Furthermore, unlike neuraxial analgesia techniques, this approach circumvents serious complications associated with neuraxial techniques, such as nerve injury, dural puncture, or epidural hematoma.
In addition to median sternotomy, chest drains placed in the subxiphoid region following cardiac surgery are also a significant source of postoperative pain. This pain may result from factors such as the skin incision, continuous irritation of surrounding tissues, and direct damage to the rectus abdominis muscle caused by the chest drains. Severe postoperative pain developing in the epigastric region can disrupt respiratory mechanics, increasing the risk of pulmonary complications and leading to a delay in the extubation process.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided written informed consent
- •Open-heart surgery performed under elective conditions via median sternotomy with cardiopulmonary bypass (on-pump)
- •American Society of Anesthesiologists (ASA) physical status class II or III
- •Aged 18-70 years
排除标准
- •Off-pump surgical procedure
- •Emergency or repeat cardiac surgery
- •Known allergy to induction agents or local anesthetics
- •Body mass index (BMI) >35 kg/m²
- •Coagulopathy
- •Infection at the surgical site
- •Left ventricular ejection fraction (LVEF) <40%
- •Renal insufficiency (estimated glomerular filtration rate <60 mL/min/1.73 m²) or hepatic insufficiency [Presence of major systemic diseases such as acute decompensated cirrhosis characterized by bilirubin >12 mg/dL, INR >2.5, or hepatic encephalopathy, in accordance with the European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria]
- •Psychiatric disorders
- •History of chronic pain or regular use of analgesics (corticosteroids, analgesics, anticonvulsants)
- •Cognitive impairments that could interfere with the assessment of postoperative pain
- •Patients with impaired physical and verbal performance
研究组 & 干预措施
Group PRI
Bilateral retro-intercostal fascial plane block (RIFB) will be administered in addition to bilateral PIFB.
干预措施: Ultrasound-Guided Recto-Intercostal Fascial Plane Block (Procedure)
Group P
Bilateral pectointercostal fascial plane block (PIFB) will be administered.
干预措施: Ultrasound-Guided Pectointercostal Fascial Plane Block (Procedure)
Group PRS
Bilateral rectus sheath block (RSB) will be administered in addition to bilateral PIFB.
干预措施: Ultrasound-Guided Pectointercostal Fascial Plane Block (Procedure)
Group PRS
Bilateral rectus sheath block (RSB) will be administered in addition to bilateral PIFB.
干预措施: Ultrasound-Guided Rectus Sheath Block (Procedure)
Group PRI
Bilateral retro-intercostal fascial plane block (RIFB) will be administered in addition to bilateral PIFB.
干预措施: Ultrasound-Guided Pectointercostal Fascial Plane Block (Procedure)
结局指标
主要结局
Turkish version of the Quality of Recovery-15 scale (QoR-15T)
时间窗: In the postoperative period, the time of extubation will be considered "postoperative hour 0". The primary endpoint is the quality of early recovery, assessed at 24 hours postoperatively.
The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).
次要结局
- Turkish version of the Quality of Recovery-15 scale (QoR-15T)(In the postoperative period, the time of extubation will be considered "postoperative hour 0". QoR-15T scores will be reassessed at 48 hours postoperatively and prior to discharge.)
- The Numerical Rating Scale (NRS)(All cases will be assessed using the NRS at 0, 3, 6, 12, 24, 36, and 48 hours after extubation.)
- Total Tramadol Consumption(Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use.)
- Opioid-Related Adverse Effects During the Postoperative Observation Phase(Until hospital discharge (approximately 5-7 days))
- Complications Associated with Fascial Plane Blocks(Until hospital discharge (approximately 5-7 days))
研究者
Yasir Ilyas, MD
Assistant Professor
Ordu University