NCT01855529已完成2 期
ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.
Centre Jean Perrin1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Daily consumption of morphine during the first 48 postoperative hours.
研究概览
简要总结
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.
Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.
Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •ASA I-II, WHO 0-1
- •mastectomy alone, mastectomy + GGS + mastectomy CA
- •No previous history of chronic pain requiring regular intake of analgesics or long-term
- •Failure to take opioids within 30 days before surgery
排除标准
- •Long-term treatment analgesic or taking opioids within 30 days before surgery
- •Concurrent treatment with a drug test, participation in another therapeutic clinical trial within <30 days
- •proven allergy to local anesthetics of the amide
- •Skin Inflammation
- •Sepsis local
- •Kidney failure, liver failure, severe or poorly controlled diabetes
- •Inability to respond to the assessment of pain using a visual analogue scale (VAS) or a numerical scale (FR).
- •mastectomy with immediate breast reconstruction
研究组 & 干预措施
Ropivacaine arm
Experimental
Ropivacaïne 2 mg/ml 10ml/h
干预措施: Ropivacaine in one arm and placebo (NaCl) in the other arm (Drug)
NaCl arm
Placebo Comparator
NaCl 0,9% 250ml 10 ml/h
干预措施: Ropivacaine in one arm and placebo (NaCl) in the other arm (Drug)
结局指标
主要结局
Daily consumption of morphine during the first 48 postoperative hours.
时间窗: during the first 48 postoperative hours
次要结局
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The intensity of pain, VAS or EN(During the first 48 h after surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects The most common expected morphine: nausea, vomiting, pruritus, acute urine retention.(during the 48h after the surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The site of pain(during the first 48h after the surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Determination of Ropivacaine plasma at T0+ 24 h, T0+48h(during 48h after the surgery)
- Determination of Ropivacaine plasma (analytical blank: T0)(T0, the day of surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: A potential analgesics administered(during the first 48h after the surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Constant: pulse, blood pressure, tympanic temperature, respiratory rate, sedation (0: awake, 1: sleepy, 2 comatose).(during 48h after the surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects of ropivacaine expected the most common: nausea, vomiting, headache, dizziness, paresthesias.(during 48 hours after the surgery)
- Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Condition of dressing • On any abnormality at the site of administration: local redness, pain, skin warmth, pruritus.(during the 48h after the surgery)
研究者
研究点 (1)
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