Off-pump Minimal Invaziv Koroner Arter Bypass Cerrahisi geçiren Hastalarda Serratus Posterior Superior Interkostal Plan Blokunun Analjezik etkinliği: Randomize kontrollü çalışma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Recovery-15 (QoR-15) Score
研究概览
简要总结
Postoperative pain after cardiac surgery is commonly moderate to severe due to sternotomy, thoracotomy, internal mammary artery harvesting, and chest tube placement, and may contribute to adverse systemic and pulmonary outcomes if inadequately managed. Enhanced Recovery After Surgery (ERAS) protocols emphasize opioid-sparing strategies to reduce opioid-related side effects and complications. Ultrasound-guided fascial plane blocks have increasingly been incorporated into perioperative analgesia protocols for cardiac surgery. The serratus posterior superior intercostal plane block (SPSIPB), a recently described technique, provides wide dermatomal sensory coverage and may offer effective analgesia in thoracic and cardiac surgical procedures.
This prospective, randomized controlled study aims to evaluate the analgesic efficacy of SPSIPB in adult patients undergoing off-pump minimally invasive coronary artery bypass grafting (CABG). A total of 60 ASA III patients aged 18 years or older will be randomized into two groups: SPSIPB group and control group. The SPSIPB will be performed preoperatively under ultrasound guidance using 0.25% bupivacaine, while the control group will receive standard general anesthesia without any plane block. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia with tramadol.
The primary outcome of the study is postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include intraoperative remifentanil consumption, postoperative opioid requirements, time to first rescue analgesia, numerical rating scale (NRS) pain scores at rest and during coughing, extubation time, intensive care unit and hospital length of stay, and postoperative complications such as nausea, vomiting, and atelectasis. This study aims to determine whether SPSIPB can improve postoperative recovery quality and reduce opioid consumption in patients undergoing off-pump minimally invasive CABG.
详细描述
Introduction
Pain after cardiac surgery is commonly moderate to severe due to sternotomy, sternal retraction, internal mammary artery harvesting, thoracotomy/thoracoscopy in minimally invasive approaches, and chest tube placement. Adequate pain management reduces pain-related systemic and pulmonary complications. Tachycardia and hypertension secondary to pain increase myocardial oxygen consumption and predispose patients to hemodynamic instability.
Enhanced Recovery After Surgery (ERAS) protocols aim to reduce opioid consumption and eliminate opioid-related adverse effects. With increasing awareness of opioid overuse, tolerance, and opioid-induced hyperalgesia, opioid-sparing analgesic strategies have gained importance. The most critical component of opioid-sparing analgesia is the use of regional anesthesia techniques. Procedure-Specific Postoperative Pain Management (PROSPECT) guidelines recommend plane blocks as part of analgesic management in thoracic surgeries. The incidence of severe chronic pain within the first year after sternotomy has been reported to be approximately 35%. Various regional anesthesia techniques, including thoracic epidural anesthesia, thoracic paravertebral block, and parasternal intercostal block, have been used for postoperative analgesia in cardiac surgery. However, coagulation disorders limit the application of central neuraxial blocks. Ultrasound-guided fascial plane blocks have therefore been increasingly adopted in cardiac surgery. These include erector spinae plane block (ESPB), serratus anterior plane block, parasternal block, paravertebral block (PVB), pectoral nerve blocks (PECS I-II), and serratus posterior superior intercostal plane block (SPSIPB).
Ultrasound-guided SPSIPB was first described by Tulgar et al. in 2023 through cadaveric studies and a case series of five patients. Due to its wide local anesthetic spread and extensive sensory dermatomal coverage (C3-T10), SPSIPB has been increasingly used in cervical and thoracic surgical procedures.
In our clinic, coronary artery bypass grafting (CABG) procedures are performed on the beating heart, with the aim of accelerating postoperative recovery. Effective intraoperative and postoperative analgesia facilitates optimal surgical conditions and postoperative management. Therefore, regional anesthesia techniques are frequently employed to enhance analgesic efficacy. In this study, we aimed to evaluate the effectiveness of serratus posterior superior intercostal plane block (SPSIPB) in postoperative analgesia management for off-pump CABG surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation. The anesthesiologist performing the block will not be blinded due to the nature of the intervention.
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
- 是
入选标准
- •Patients aged 18-75 years
- •ASA physical status II-III
- •Scheduled for elective off-pump minimally invasive coronary artery bypass grafting (CABG) surgery
- •Ability to understand and use the Numerical Rating Scale (NRS)
- •Ability to provide written informed consent
排除标准
- •Refusal to participate in the study
- •Known allergy or contraindication to local anesthetics
- •Coagulation disorders or ongoing anticoagulant therapy incompatible with regional anesthesia
- •Infection at the block injection site
- •Severe hepatic or renal dysfunction
- •Chronic opioid use or opioid dependence
- •History of chronic pain syndromes
- •Severe pulmonary disease (e.g., advanced COPD)
- •Neurological or psychiatric disorders that may interfere with pain assessment
- •Emergency surgery
- •Conversion to on-pump CABG or sternotomy during surgery
研究组 & 干预措施
SPSIPB Group
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) prior to induction of general anesthesia. The block will be performed under sterile conditions with the patient in the lateral position using a high-frequency linear ultrasound probe. After identification of the third rib, serratus posterior superior muscle, and pleura, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib, with confirmation of cranio-caudal spread under ultrasound guidance. All patients will then undergo standardized general anesthesia and postoperative analgesia according to the institutional protocol.
干预措施: Serratus Posterior Superior Intercostal Plane Block (SPSIPB) (Procedure)
SPSIPB Group
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) prior to induction of general anesthesia. The block will be performed under sterile conditions with the patient in the lateral position using a high-frequency linear ultrasound probe. After identification of the third rib, serratus posterior superior muscle, and pleura, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib, with confirmation of cranio-caudal spread under ultrasound guidance. All patients will then undergo standardized general anesthesia and postoperative analgesia according to the institutional protocol.
干预措施: Bupivacaine (Drug)
SPSIPB Group
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) prior to induction of general anesthesia. The block will be performed under sterile conditions with the patient in the lateral position using a high-frequency linear ultrasound probe. After identification of the third rib, serratus posterior superior muscle, and pleura, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib, with confirmation of cranio-caudal spread under ultrasound guidance. All patients will then undergo standardized general anesthesia and postoperative analgesia according to the institutional protocol.
干预措施: Ultrasound (Device)
Control Group
Participants in this group will receive standardized general anesthesia without any regional or fascial plane block. Intraoperative anesthesia management and postoperative analgesia, including patient-controlled analgesia with tramadol, will be administered according to the same institutional protocol used for the intervention group.
结局指标
主要结局
Quality of Recovery-15 (QoR-15) Score
时间窗: 24 hours postoperatively
The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing postoperative recovery quality across five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Higher scores indicate better recovery quality.
次要结局
- Postoperative Pain Scores (NRS)(Postoperative 30 minutes, and at 1, 6, 12, 18, and 24 hours)
- Postoperative Total Opioid Consumption(First 24 hours postoperatively)
- Intraoperative Remifentanil Consumption(From induction of anesthesia to the end of surgery)
- Time to First Rescue Analgesia(Within the first 24 hours postoperatively)
- Time to Extubation(Immediately postoperative period (within the first hours after surgery))
研究者
Mustafa Burgaç
Specialist physician
Kartal Kosuyolu High Speciality Training and Research Hospital