Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Opioids consumption
研究概览
简要总结
Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male
- •18 years or older
- •Liposuction and lipoabdominoplasty
- •ASA 1 and 2
- •BMI 21-28 Kg/m2
- •Full secondary education
排除标准
- •Patients with surgeries added to the main proceedings
- •Scheduled to tuck in Flor de Lis or Body Lift
- •History of use of analgesic drugs 48 hours before surgery
- •Peripheral central neurological diseases
- •Known allergy will be excluded to medication in use in this study (ketamine, magnesium, clindamycin and penicillin or other)
研究组 & 干预措施
Control group (C)
50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)
干预措施: Saline (Drug)
Ketamine group (K)
50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)
干预措施: Ketamine (Drug)
Magnesium + ketamine group (MGK)
50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)
干预措施: Ketamine + magnesium (Drug)
结局指标
主要结局
Opioids consumption
时间窗: 12 h after surgery
Postoperative Pain (Postoperative Pain and Disability Scale)
时间窗: 2, 7, 14, 21, 45 and 90 days after surgery
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
次要结局
- Early postoperative pain (Visual analogue pain scale)(0, 2, 4, 6, 12 and 24 h after surgery)
- Disability (Time delay in returning to work)(90 days)
- Early postoperative pain (Time to first request for supplemental analgesia)(1 day)
- Postoperative Chronic Pain (McGill scale)(Day after surgery, 7, 30 and 90 days after surgery)
研究者
Veronica Varas Vega
MD
University of Chile