Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Class II analgesic consumption between the 2 arms
研究概览
简要总结
The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.
For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.
The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years old
- •Patient needing a thin skin graft < 320 cm2 and which is possible on the thigh
- •Patient who read the information letter and signed the informed consent
- •Patient affiliated at a social security system
- •Effective contraceptive method for more than 3 months for women of childbearing age
排除标准
- •Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction)
- •Treatment by classII or III of analgesics or analgesic dose of aspirin(>500mg per day) at the inclusion or randomization time
- •Preoperative EVA>0 at the skin graft donor site on the thigh
- •Sensory disturbances of the lower limbs
- •Cognitive disturbances not allowing investigations
- •Pregnant or lactating women
- •People deprived of discernment
- •People deprived of their liberty by judicial or administrative authority
- •Protected adult (guardianship or trusteeship)
研究组 & 干预措施
DRUG : ROPIVACAINE
20 mL topically used during alginate dressing
干预措施: 20 mL topically used during alginate dressing NAROPEINE (Drug)
PLACEBO : NaCl 0.9 %
20 mL topically used during alginate dressing
干预措施: 20 mL topically used during alginate dressing NaCl (Drug)
结局指标
主要结局
Class II analgesic consumption between the 2 arms
时间窗: 5 days post-operative
Evaluate the effect of ropivacaine in topical use on an alginate dressing by evaluating the use of class II analgesic medicines in patient who had a thin skin graft
次要结局
- Class II antalgic consumption between the 2 arms(Day 90)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(day 90)