The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post-operative pain scores
研究概览
简要总结
Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.
详细描述
The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
- •undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
- •day surgery procedures
排除标准
- •inability to understand or to provide consent
- •inability or unwillingness to comply with required follow-up assessments
- •psychiatric disorder affecting patient assessment
- •contraindication to regional anesthesia, e.g., coagulopathy
- •allergy to local anesthestic
- •chronic pain and/or chronic use of opioids with a daily use of over 30mg oxycodone or equivalent per day
- •contraindication to a component of multimodal analgesia
- •preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
- •infection near the injection site
- •pregnancy
- •complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes
研究组 & 干预措施
Serratus Block Group
Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia
干预措施: Serratus Block (Procedure)
Serratus Block Group
Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia
干预措施: ropivacaine (Drug)
Serratus Block Group
Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia
干预措施: epinephrine (Drug)
Placebo Block - Control Group
Patients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia.
干预措施: Placebo Block (Procedure)
Placebo Block - Control Group
Patients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia.
干预措施: sterile saline (Other)
结局指标
主要结局
Post-operative pain scores
时间窗: Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..
The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS). The mean of these scores at the 3 different time points will be calculated.
次要结局
- Intraoperative opioid consumption(Duration of actual surgical procedure)
- Post-operative opioid consumption(End of surgical procedure until 7 days after surgery)
- Duration phase I and phase II recovery(Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,)
- Opioid side-effects(End of surgical procedure to 7 days following surgery)
- Block-related side-effects(Completion of block to 3 months postoperatively)
- Satisfaction with analgesia(End of surgical procedure to 3 months postoperatively)
- Quality of recovery score (QoR)(Discharge from hospital until 24 hours post-op)
- Pain assessment(Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.)