Double-blind Randomized Prospective Phase III Study of a Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment of the Postoperative Pain From Hospital to Home
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Delay to obtain the three criteria of premature recovery after mastectomy
研究概览
简要总结
The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements.
Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure.
Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy.
The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner).
Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Women > 18 years,
- •Operated for a breast cancer by mastectomy with or without lymph node dissection, without immediate reconstruction,
- •Capable of understanding the antalgic protocol,
- •No contraindication to the local anesthesics,
- •Social security affiliation,
- •Signed informed consent.
排除标准
- •Preoperative radiotherapy,
- •Local infection,
- •Contra-indication to the local anesthetic or to CCP,
- •Contra-indication for the use of morphine,
- •Contra-indication for the use of remifentanil,
- •Addiction to opioid analgesics know or not,
- •Allergy to local anesthetics,
- •Hepatic or renal impairment grim known,
- •Previous surgery on the operated breast,
- •Pregnant women, or child-bearing potential, or lactating women,
- •Patient deprived of liberty or under supervision of a guardian.
研究组 & 干预措施
placebo
physiological saline
干预措施: physiological saline (Drug)
Ropivacaine
Ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Delay to obtain the three criteria of premature recovery after mastectomy
时间窗: time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).
Delay to obtain the three criteria of premature recovery after mastectomy until 3 months post surgery:satisfactory analgesia defined by a Digital Scale lower than 4, estimated at rest and after standardized mobilization in immediate postoperative, and recourses or not to an analgesia of help, and capacity to drink with a glass and to thread the sleeve of a garment with the member side of the operated breast.
次要结局
- pain intensity(time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).)
- Analgesics consumption measure(time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).)
- Measure of side effects rate(from surgery up to 3 days after the end of treatment)
- quality of life evaluation(time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 1 and month 3).)