Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption (need and demand as microgram)
研究概览
简要总结
Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.
详细描述
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.
The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.
The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).
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)
盲法说明
The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-II
- •Scheduled for mastectomy and axillary dissection surgery under general anesthesia
排除标准
- •anticoagulant treatment,
- •known local anesthetic allergy,
- •infected skin around the block site,
- •pregnancy or breast-feeding,
- •back abnormalities
研究组 & 干预措施
Group 30 = 30 ml of Erector spinae plane block group
In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
干预措施: Bupivacaine + Fentanyl (Drug)
Group 20 = 20 ml of Erector spinae plane block group
In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.
干预措施: Bupivacaine + Fentanyl (Drug)
结局指标
主要结局
Postoperative opioid consumption (need and demand as microgram)
时间窗: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device. The parameters on PCA devices such as delivery and demand will be assessed
次要结局
- Pain scores (Visual analogue scores-VAS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours)
研究者
Bahadir Ciftci
Principal Investigator
Medipol University