Evaluation of the Effectiveness of Serratus Posterior Superior Intercostal Plane Block in Perioperative Pain Management in Patients Undergoing Minimally Invasive Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total opioid consumption within 24 hours after surgery
研究概览
简要总结
This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.
详细描述
Minimally invasive cardiac surgery (MICS) is increasingly performed as an alternative to traditional sternotomy-based procedures, providing benefits such as shorter recovery time, reduced hospital stay, and improved cosmetic outcomes. However, despite smaller incisions, patients frequently experience moderate to severe postoperative pain due to rib, pleural, and intercostal nerve injury. Uncontrolled pain may impair respiratory function, delay mobilization, and increase postoperative complications, including chronic post-thoracotomy pain.
Regional anesthesia techniques play an important role in multimodal analgesia after MICS, but the optimal approach remains uncertain. Thoracic epidural and paravertebral blocks have been widely used but are often limited by safety concerns in anticoagulated patients. Recently, ultrasound-guided interfascial plane blocks have gained attention due to their simplicity and low complication rates. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB), first described in 2023, targets the fascial plane between the serratus posterior superior and intercostal muscles, typically at the second or third intercostal level, and provides broad sensory coverage from C3 to T10 dermatomes. To date, there is no published study investigating its use for pain control in MICS.
This study will be conducted at Ankara Bilkent City Hospital as a prospective, randomized, controlled, single-center clinical trial. A total of 50 patients (25 per group) aged 18-75 years (ASA II-III) scheduled for MICS will be enrolled after obtaining informed consent. Participants will be randomly assigned (1:1) to one of two groups using a computer-based randomization method:
Group SPSIPB (n=25): Standard anesthesia and analgesia + ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine (unilateral, on the surgical side).
Group Control (n=25): Standard anesthesia and analgesia only. All patients will receive intravenous tramadol (1 mg/kg) and paracetamol (1 g) at the end of surgery. Postoperative patient-controlled analgesia (PCA) with tramadol (15 mg bolus, 15-min lockout, no basal infusion) will be used in both groups. Rescue morphine (0.05 mg/kg) will be administered when NRS >4. Pain scores (NRS 0-10) will be recorded at 6, 12, and 24 hours postoperatively, both at rest and during deep breathing/coughing.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The anesthesiologist performing the block will be aware of group allocation, while the patients and the anesthesiologist responsible for postoperative data collection will remain blinded to the intervention. Pain assessments and other outcome measurements will be conducted by a blinded senior anesthesia resident who is unaware of which treatment each patient received.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective minimally invasive cardiac surgery (MICS)
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Body mass index (BMI) between 18 and 35 kg/m²
- •Patients who provide written informed consent for participation
排除标准
- •Known allergy or hypersensitivity to local anesthetics
- •Coagulopathy or current anticoagulant therapy
- •Pregnancy or breastfeeding
- •Impaired consciousness or inability to communicate
- •Failed or technically inadequate block
- •Refusal to undergo the block procedure
- •Cognitive or mental disorders preventing valid pain assessment
- •Opioid intolerance or contraindication to opioid use
- •Development of intraoperative or postoperative complications requiring reoperation, prolonged mechanical ventilation, or intensive care
- •Incomplete postoperative data or patient withdrawal from the study
研究组 & 干预措施
SPSIPB Group
Patients in this group will receive ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with 30 mL of 0.25% bupivacaine in addition to standard anesthesia and analgesia.
干预措施: Serratus Posterior Superior Intercostal Plane Block (SPSIPB) (Procedure)
Sham Block Group
Patients in this group will undergo the same ultrasound-guided block procedure using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. All other anesthesia and analgesia protocols will be identical to the experimental group.
干预措施: Sham Serratus Posterior Superior Intercostal Plane Block (Procedure)
结局指标
主要结局
Total opioid consumption within 24 hours after surgery
时间窗: 24 hours postoperatively
The total amount of opioids (converted to intravenous morphine equivalent, mg) administered during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device and rescue analgesic doses.
次要结局
- Modified Radiological Atelectasis Score(24 and 48 hours postoperatively)
- Block-related complications(Within 24 hours postoperatively)
- Postoperative pain scores (NRS)(6, 12, and 24 hours postoperatively)
- Intraoperative opioid consumption(During surgery)
- Extubation time(Immediate postoperative period)
- Postoperative recovery parameters(Within 48 hours postoperatively)
- Quality of Recovery (QoR-15) score(24 and 48 hours postoperatively)
研究者
Nisan Özsan
Principal Investigator
Ankara City Hospital Bilkent