Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparing morphine consumption rates within 24h postoperative
研究概览
简要总结
Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain.
However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast.
Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax.
The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery.
There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain.
The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
详细描述
It is a prospective double blind trial. Sixty female patient aged between 20-65 years old with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgery for breast cancer were included in the study. Only unilateral surgical procedures will be included. The patients will be randomized into two groups:
Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction of general anesthetic.
Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in almost identical fashion to that of the ESP block.
Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) will be applied.
All blocks will be performed before induction of general anesthesia.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •25-65 years old
- •Undergoing unilateral breast cancer surgery
排除标准
- •obesity (body mass index >40 kg/m2)
- •Preoperative chronic dependence upon opioid and NSAID medications
- •History of psychiatric or neurological disease
- •Patients with chronic pain syndromes
- •allergy to local anaesthetics
- •other contraindications to peripheral nerve blocks
- •Patients' refusal to participate
结局指标
主要结局
Comparing morphine consumption rates within 24h postoperative
时间窗: The first 24 hours postoperative
All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.
次要结局
- Time to first request for morphine(During 24 hours postoperative)
- Assessment of pain in postoperative period via visual analogue scales (VAS) .(The first 24 hours postoperative)
- Total morphine demand(During 24 hours postoperative)
- Requirement of rescue analgesia(During 24 hours postoperative)
- Morphine related side effects(During 24 hours postoperative)
- Total intraoperative consumption of Fentanyl.(Intraoperative period)
- Postoperative nausea and vomiting(within 24 hours postoperative)
研究者
Ben marzouk Sofiene
clinical associate professor
University Tunis El Manar