Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 66
- 主要终点
- Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).
研究概览
简要总结
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation
详细描述
One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.
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, Investigator)
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
- •Women> 18 and <= 65 years
- •Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
- •ASA I and II
- •Informed consent signed
排除标准
- •Rejection of the patient
- •ASA III or higher
- •Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness).
- •Allergy to NSAIDs, local anesthetics and / or morphine
- •Patients treated for chronic pain
- •Placement of drains for surgical needs
研究组 & 干预措施
levobupivaciane group
Levobupivacaine group (L- bupivacaine 0,25% -2,5 mg/ml-) 60 ml. Total dosis in topical use 150 mg (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively).
干预措施: Levobupivacaine (Drug)
Placebo Comparator (saline solution)
Placebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively).
干预措施: Placebo (Drug)
结局指标
主要结局
Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).
时间窗: at 6 hours the early postoperative period (after the end of anesthesia)
次要结局
未报告次要终点
研究者
Severiano Marin Bertoli
PhD
General University Hospital of Valencia