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临床试验/NCT00591487
NCT00591487Unknown3 期

Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.

Hospital Militar de Santiago1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
60
试验地点
1
主要终点
Pain (VSA)

研究概览

简要总结

RCT of S/E of lidocaine infiltration in tumescent technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • I or II of the Classification of the American Society of Anesthesiologists.
  • Completed high school.
  • Between 18 and 40 years old
  • At least suction of entire abdomen and back
  • Body mass index between 20 and 27
  • Accept written informed consent

排除标准

  • Associated surgery
  • Hypersensibility to (Cefazolin or Clindamycin, Lidocaine, Ketorolac, Morphine, Remifentanyl, Propofol, Tramadol).
  • Pregnancy
  • Previous surgery to abdominal wall or back, including cesarean.
  • Abdominal wall hernia
  • Previous liposuction
  • Active psychosis

研究组 & 干预措施

I

Active Comparator

Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine

干预措施: Lidocaine (Drug)

II

Placebo Comparator

Infiltration with 0.9% saline+1:1,000,000 epinephrine

干预措施: Lidocaine (Drug)

结局指标

主要结局

Pain (VSA)

时间窗: 1, 6, 12, 18 and 24 post operative hours

次要结局

  • Rescue medication(1, 6, 12, 15 and 24 hours postoperative)
  • Nausea, emesis, arrythmia, seizures, arrest, shock, death.(24 hours postoperative)

研究者

发起方
Hospital Militar de Santiago
申办方类型
Other

研究点 (1)

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