Mastektomi Planlanan Hastalarda Serratus Posterior Superior İnterkostal Plan Bloğu Ile Serratus Anterior Plan Bloğunun Peroperatif Analjezi Yönetimi Üzerine Etkilerinin Araştırılması
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency.
In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients.
The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.
详细描述
Postoperative pain following mastectomy surgery remains a significant clinical concern, as it negatively impacts patient comfort, delays recovery, and may prolong hospital stay. Effective pain management is essential not only to improve patient satisfaction but also to reduce complications associated with delayed mobilization. Although systemic opioids and other analgesics are frequently used, they are associated with adverse effects such as sedation, nausea, constipation, and risk of dependency. Therefore, regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies.
Ultrasound-guided interfascial plane blocks, such as the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, have been shown to provide effective analgesia for thoracic and breast surgeries by targeting similar dermatomal distributions. However, comparative data regarding their relative efficacy in mastectomy patients are limited. This study aims to compare these two techniques in terms of postoperative analgesia and recovery outcomes.
Female patients aged between 18 and 75 years, classified as ASA physical status I, II, or III, and scheduled for elective mastectomy will be included in the study after obtaining written informed consent. Patients will be randomly assigned into two groups.
In Group 1, patients will receive an ultrasound-guided SAP block using a linear probe under aseptic conditions. The block will be performed in the lateral decubitus position by advancing the needle between the second and seventh ribs to the plane beneath the serratus anterior muscle, and 30 mL of 0.25% bupivacaine will be administered.
In Group 2, patients will receive an ultrasound-guided SPSIP block under aseptic conditions in the sitting position. The needle will be inserted medially to the scapula between the second and seventh ribs, targeting the plane between the serratus posterior superior muscle and intercostal muscles, and 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) will be administered.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 75 years
- •Patients scheduled for elective mastectomy surgery
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Patients who provide written informed consent
排除标准
- •Patients who refuse to participate in the study
- •Patients with American Society of Anesthesiologists (ASA) physical status IV or V
- •Patients receiving anticoagulant therapy or with suspected coagulopathy
- •Patients with known allergy to local anesthetic agents
- •Infection at the site of block application
- •Pregnant patients or those with suspected pregnancy
- •Patients with severe neurological or psychiatric disorders
- •Patients with severe cardiovascular disease
- •Patients with chronic opioid use
- •Patients with hepatic failure or renal failure (glomerular filtration rate <15 mL/min/1.73 m²)
研究组 & 干预措施
SAPB Group
Patients in this group will receive Serratus Anterior Plane Block for postoperative analgesia.
干预措施: SAP Block (Procedure)
SPSIPB Group
Patients in this group will receive Serratus Posterior Superior Intercostal Plane Block for postoperative analgesia.
干预措施: SPSIP Block (Procedure)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Within 48 hours postoperatively
Postoperative pain intensity and time to first analgesic requirement will be evaluated. Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at 0 and 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours postoperatively, both at rest and during movement, by a blinded investigator
次要结局
- Total Analgesic Consumption(Within 48 hours postoperatively)
- Additional Analgesic Requirement(Within 48 hours postoperatively)
- Intraoperative Opioid Consumption(During surgery)
- Intraoperative mean arterial pressure (mmHg)(Every 30 minutes intraoperatively)
- Postoperative Complications(Within 48 hours postoperatively)
- Pain During First Mobilization(Within 48 hours postoperatively)
- Patient satisfaction score(At the 24th hour post-operation)
- Surgeon satisfaction score(Within 24 hours postoperatively)
研究者
Muhammed Alihan Mol
Anesthesiology Resident
Uludag University