Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Acute Pain Management in Open-Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption in the first 24 hours after surgery
研究概览
简要总结
The aim of this study is to investigate the efficacy of bilateral serratus posterior superior intercostal plane (SPSIP) block on postoperative acute pain and opioid consumption in patients undergoing on-pump open-heart surgery. Postoperative outcomes including pain scores, cumulative morphine use, quality of recovery, and opioid-related side effects will be evaluated within the first 24 hours after surgery.
详细描述
Acute pain following cardiac surgery is a prevalent clinical problem that may negatively affect postoperative recovery, pulmonary function, and overall quality of life. Reported rates of moderate to severe pain after sternotomy range widely in the literature, largely due to factors such as vasospasm, heightened inflammatory responses, tissue and bone trauma during surgical dissection, and the placement of chest tubes. Although pain intensity usually subsides after the first 24 hours, inadequate analgesia during this critical period can prolong acute pain, delay mobilization, and increase the risk of chronic post-sternotomy pain syndrome.
Traditionally, neuraxial techniques such as thoracic epidural and paravertebral blocks have been used for pain management in cardiac surgery. However, their application remains controversial due to technical difficulties and patient-related risks, including coagulation disorders, complete heparinization, hemodynamic instability, and potential complications such as pneumothorax. In recent years, fascial plane chest wall blocks, including serratus anterior, parasternal blocks and erector spinae plane blocks, have gained traction as safer alternatives, particularly in patients receiving antiplatelet or anticoagulant therapy.
The serratus posterior superior intercostal plane (SPSIP) block, first described in 2023, represents a novel approach for thoracic analgesia, providing extensive dermatomal coverage from C3 to T10. By targeting the fascial plane between the serratus posterior superior and intercostal muscles, this block offers the potential for effective analgesia across cervical and thoracic regions. Preliminary reports and case series have demonstrated its promising role in thoracic and minimally invasive cardiac surgery.
This prospective, randomized, double-blind, parallel-group trial will evaluate the efficacy of bilateral SPSIP block in patients undergoing on-pump open-heart surgery. Participants will be allocated to either:
SPSIP Group: General anesthesia + SPSIP Block + Patient-Controlled Analgesia (PCA)
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)
盲法说明
Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
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
- •Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.
- •American Society of Anesthesiologists (ASA) classification II-III patients.
- •Patients who can use PCA.
- •Patients who will sign the informed consent form.
排除标准
- •History of opioid use for more than four weeks
- •Chronic pain syndromes
- •Patients with a history of local anesthetic or opioid allergy, hypersensitivity
- •Alcohol and drug addiction
- •Conditions where regional anesthesia is contraindicated
- •Failure in the dermatomal examination performed after the block
- •Emergency surgeries and redo surgeries.
- •Individuals with obstructive sleep apnea.
- •Left ventricular ejection fraction less than 30%.
- •Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales.
- •Pregnant and breastfeeding patients.
- •Hematological disorders.
- •Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease). • Patients who cannot be extubated within the first 6 hours postoperatively.
研究组 & 干预措施
Group SPSIP
A bilaterally Serratus Posterior Superior Plane Block (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: Bilateral ultrasound guided Serratus Posterior Superior Plane Block (Procedure)
Group SPSIP
A bilaterally Serratus Posterior Superior Plane Block (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: IV morphine patient-controlled analgesia (Drug)
Group Control
A bilaterally Sham block + IV morphine patient-controlled analgesia (PCA)
干预措施: IV morphine patient-controlled analgesia (Drug)
Group Control
A bilaterally Sham block + IV morphine patient-controlled analgesia (PCA)
干预措施: Bilateral ultrasound guided Sham Block (Procedure)
结局指标
主要结局
Cumulative opioid consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.
Cumulative opioid consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.
次要结局
- Cumulative opioid consumption in the first 12 hours after surgery(Postoperative12 hours)
- Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
- Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 250 minutes)
- The patient number of Rescue antiemetic Requirement(Postoperative day 1)
- Patients' satisfaction and quality of pain management(preoperative day 1 and Postoperative day 1)
- The number of patients who required rescue analgesia.(Postoperative day 1)
- Cumulative opioid consumption in the first 12 hours after surgery(Postoperative12 hours)
- Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
- Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 250 minutes)
- Time to First Opioid Demand via PCA(Postoperative day 1)
- The patient number of Rescue antiemetic Requirement(Postoperative day 1)
- The number of patients with complications(Postoperative 7 days on an average)
- Patients' satisfaction and quality of pain management(preoperative day 1 and Postoperative day 1)
研究者
BURHAN DOST
Principal Investigator
Ondokuz Mayıs University