Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal and Subserratus Plane Block Versus Erector Spinae Plane Block in Modified Radical Mastectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- 24-hour postoperative tramadol consumption
研究概览
简要总结
Breast cancer is one of the most common malignancies and represents an important public health problem. Modified radical mastectomy (MRM) is frequently associated with acute postoperative pain resulting from a combination of somatic and neuropathic mechanisms. Inadequately controlled postoperative pain may impair recovery, delay mobilization, increase opioid consumption, and negatively affect patient satisfaction and quality of life. Therefore, effective multimodal analgesia is an important component of perioperative care in patients undergoing breast surgery.
Ultrasound-guided regional anesthesia techniques have gained increasing attention because they can provide effective postoperative analgesia while reducing opioid requirements and opioid-related adverse effects. The erector spinae plane block (ESPB) and rhomboid intercostal and subserratus plane (RISS) block are ultrasound-guided fascial plane techniques that may provide analgesia for thoracic and breast surgery.
The aim of this randomized controlled study is to compare the postoperative analgesic efficacy of ultrasound-guided ESPB and RISS block in patients undergoing modified radical mastectomy and sentinel lymph node excision. The primary objective is to compare postoperative opioid consumption between the two techniques. Secondary outcomes include postoperative pain scores, analgesic requirements, and patient satisfaction.
The hypothesis of the study is that ESPB and RISS block are comparable in terms of postoperative analgesic efficacy and that neither technique is superior to the other.
详细描述
Breast cancer is one of the most common types of cancer worldwide and represents a major public health concern (1). Treatment options depend on the stage and pathological characteristics of the disease and may include radiotherapy, neoadjuvant systemic therapies, breast-conserving surgery, and mastectomy (2).
Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may arise from a combination of nociceptive and neuropathic mechanisms related to surgical trauma. Inadequately controlled postoperative pain may contribute to adverse outcomes, including cardiovascular and pulmonary complications and thromboembolic events. Furthermore, acute postoperative pain may interfere with functional recovery and may contribute to the development of persistent or chronic pain, thereby negatively affecting quality of life (3). Uncontrolled postoperative pain may also prolong hospital stay, increase the risk of complications, and increase healthcare costs. Therefore, effective postoperative pain management is an important component of perioperative care in patients undergoing breast surgery (4).
Opioids remain an important component of postoperative analgesia, while nonsteroidal anti-inflammatory drugs and other non-opioid analgesics are commonly used as adjunctive therapies. However, the potential systemic adverse effects associated with these medications have increased interest in regional anesthesia techniques. Neuraxial techniques, peripheral nerve blocks, and intravenous patient-controlled analgesia can provide effective postoperative analgesia while reducing opioid requirements and facilitating postoperative recovery. In particular, ultrasound-guided regional anesthesia techniques allow real-time visualization of anatomical structures and needle advancement, potentially improving the accuracy and safety of block administration and the quality of analgesia (5).
Regional anesthesia techniques may support early postoperative mobilization and contribute to enhanced recovery after surgery (ERAS) pathways. These techniques have been reported to contribute to reducing the risk of venous thromboembolism and pulmonary complications. Improved analgesia may also facilitate deep-breathing exercises and postoperative physiotherapy. Furthermore, regional anesthesia techniques may reduce opioid and antiemetic requirements, facilitate early mobilization after mastectomy, and potentially contribute to reducing chronic postmastectomy pain (6,7).
The erector spinae muscle group extends in a craniocaudal direction on both sides of the vertebral column and lies deep to the rhomboid major muscle in the thoracic region. In an erector spinae plane block (ESPB), local anesthetic is injected into the fascial plane between the transverse process and the erector spinae muscle (8). The local anesthetic may spread in a craniocaudal direction across multiple vertebral levels. ESPB has been used for the management of acute and chronic pain and for perioperative analgesia in various thoracic and abdominal surgical procedures (8).
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
- Double (Participant, Outcomes Assessor)
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
- •Participants will be eligible for inclusion if they meet all of the following criteria:
- •Age between 18 and 80 years.
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
- •Scheduled for elective modified radical mastectomy.
- •Willingness to participate in the study and ability to provide written informed consent.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Refusal to participate in the study or inability to provide informed consent.
- •Known or suspected allergy to local anesthetic agents.
- •Coagulopathy or a contraindication to regional anesthesia.
- •Requirement for uninterrupted anticoagulant therapy.
- •Infection at the site of block injection.
- •Any other condition considered by the investigators to make participation in the study inappropriate or unsafe.
研究组 & 干预措施
ESPB(erector spinae plane block)
Participants randomized to the ESPB group will receive an ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level unilaterally.
干预措施: Erector Spinae Plane Block (Other)
RISSb(rhomboid intercostal subserratus plane block)
Participants randomized to the RISS group will receive an ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block unilaterally.
干预措施: Rhomboid Intercostal and Sub-Serratus block (Other)
结局指标
主要结局
24-hour postoperative tramadol consumption
时间窗: From the end of surgery to 24 hours postoperatively
Total tramadol consumption during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device. The total amount of tramadol administered through the PCA device will be compared between the ESPB and RISS groups.
次要结局
- Postoperative static pain intensity assessed by the Numeric Rating Scale (NRS)(Postoperative 0, 1, 2, 4, 6, 12, and 24 hours)
- Postoperative dynamic pain intensity assessed by the Numeric Rating Scale (NRS)(Postoperative 0, 1, 2, 4, 6, 12, and 24 hours)
- Patient satisfaction with postoperative pain management assessed using a Likert scale(24 hours after surgery)
- Incidence of opioid-related adverse effects(From the end of surgery to 24 hours postoperatively)
研究者
eralp çevikkalp
associate professor
Bursa City Hospital