Comparison of Erector Spinae Plane Block and Pectoral Nerve Block for Acute and Chronic Pain in Mastectomies Outcomes: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Analgesic consumption during surgery
研究概览
简要总结
Ultrasound-guided blockage of the erector plane of the spine (known as ESP BLOCK) is a recently described block and a very useful strategy in the perioperative period as it provides effective analgesia in thoracic surgery. Ultrasound-guided type II pectoral nerve block (internationally known by the acronym Pecs II block) is a very useful strategy in the perioperative period because it provides effective analgesia in breast surgeries and can optimize results. The aim of this study is to assess perioperative pain in mastectomies. This is a prospective, randomized, single-blinded study that will compare the effects of spinal erector plane block versus pectoral nerve block in patients scheduled for mastectomy. The ESP group will receive balanced general anesthesia associated with ESP BLOCK with 0.5% ropivacaine guided by ultrasound. The Pecs II group will receive balanced general anesthesia associated with Pecs II block with 0.5% ropivacaine guided by USG.
详细描述
The integration of ultrasound with anesthesia allowed for greater safety and risk reduction in regional anesthesia, in addition to the possibility of creating new peripheral blocks that contribute to multimodal analgesia, providing greater comfort for patients in the postoperative period. The spinal erector plane block (ESP Block) and type II pectoral nerve block (PECS II block) emerge as yet another analgesia strategy for breast surgeries, as they are less invasive than thoracic epidural anesthesia and paravertebral block thoracic, reducing the risk of complications. The ESP Block was initially described for analgesia in chest surgery and for the management of chronic chest pain. PECS II block was inspired by the infraclavicular approach, and aims at anesthesia of the lateral and medial pectoral nerves, intercostobrachial, 4th, 5th and 6th intercostal nerves and the long thoracic nerves. Both are technically simple and easily reproducible.
Both are safe techniques, easy to reproduce, have a low risk of complications and allow good control of acute perioperative pain. Therefore, our study has as primary objective to compare the quality of perioperative analgesia offered by ESP Block versus PECS II block by intraoperative opioid consumption in oncologic mastectomy.
A pilot study carried out in our service indicated the superiority of PECS II block over ESP block in relation to intraoperative opioid consumption. The proposal is therefore a prospective, randomized, single-blind, superiority study to compare the hypothesis that PECS II is superior to ESP block in oncological mastectomy performed at Hospital de Base do Distrito Federal, Brasília, DF, Brazil.
The patients were randomized 1:1 by a previously generated random list (https://www.randomizer.org). The allocation sequence was kept inaccessible to all investigators during recruitment and treatment. The researcher responsible for the postoperative period, the surgical team and the patients were not aware of the allocated groups. The researcher responsible for the randomization list communicated the researcher responsible for performing the ESP or PECS II block and conducting the anesthesia.
Upon arrival in the operating room, all patients will receive standard monitoring with cardioscopy, pulse oximetry, non-invasive blood pressure and temperature. After venoclysis of the contralateral upper limb to surgery, all patients will receive 0.05 mg/kg intravenous (IV) midazolam, 1mcg/kg fentanyl for anxiolysis, and IV dexamethasone 4 mg. After anxiolysis, blockade will be performed according to the group to which the patient was previously allocated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The researcher responsible for the postoperative period, the surgical team and the patients were not aware of the allocated groups. The researcher responsible for the randomization list communicated the researcher responsible for performing the ESP or PECS II block and conducting the anesthesia.
入排标准
- 年龄范围
- 18 Years 至 70 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 70 years, electively scheduled for mastectomy at Hospital Regional de Sobradinho and Hospital de Base do Distrito Federal;
- •American Society of Anesthesiology (ASA) physical status I, II or III
排除标准
- •Patient with severe heart disease;
- •Patient with severe liver disease;
- •Patient with severe kidney disease;
- •Patient with a neurological disease;
- •Use of psychoactive drugs;
- •Pregnant women;
- •Patients with allergies to any medication used in the study;
- •Patients with chronic pain;
- •Patients who refused to participate in the study.
结局指标
主要结局
Analgesic consumption during surgery
时间窗: During the surgery
The amount of opioid analgesics consumed during surgery
次要结局
- Anesthetics consumption during surgery(During the surgery)
- Tramadol consumption in post-operative(Within the first 24 hours after surgery)
- Pain Scores on the Numeric Rating Scale(Sixth month after surgery)
- Number of participants with adverse events as a measure of safety and tolerability(Within the first 24 hours after surgery)
- Incidence of post-mastectomy chronic pain syndrome(Sixth month after surgery)
研究者
Fabricio Tavares Mendonca
Anesthesiology Residency Preceptor
Hospital de Base