A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and impact on morphine consumption of ropivacaine administered by local per and post hepatic surgery infiltration.
Patients will be randomized to either ropivacaine or physiological serum, with equivalent administration modalities in both arms.
Patients will be followed during 4 days after the surgery. They will also come back for a follow-up visit one month later.
It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.
This is a prospective, comparative, monocentric, double-blind randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Male or female patients aged ≥ 18 years
- •Patients with histologically confirmed cancer
- •Patients treated at the Centre Léon Bérard
- •Patients requiring a surgery for hepatic metastases
- •ASA <= 3
- •At least 3 weeks between surgery and chemotherapy
- •Total bilirubin < 1.5 x upper limit of normal range
- •ASAT and ALAT < 5 times x upper limit of normal range
- •Creatinine clearance > 60 ml per hour
- •Serum creatinine < 115 µmol/l
- •Mandatory affiliation with a health insurance system
- •Patients able to understand French
- •Signed, written informed consent
排除标准
- •Patients with a hepatocellular carcinoma or an initial liver cancer
- •Patients treated chronically by morphine
- •Patients that already have abdominal pain
- •Patients who are allergic either to morphinics, local anesthesics, paracetamol, NSAID or cortisone
- •Patients suffering from heart, kidney or liver insufficiency
- •Documented history of cognitive or psychiatric disorders
- •Pregnant or lactating women
- •Difficult follow-up
研究组 & 干预措施
Ropivacaine
Ropivacaine administration by local per and post surgery infiltration
干预措施: Ropivacaine (Drug)
Physiological serum
Administration of physiological serum by local per and post surgery infiltration
干预措施: Physiological serum (Drug)
结局指标
主要结局
Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption
时间窗: In the 4 days following the hepatectomy
次要结局
- Patients' post-surgery rehabilitation(Between surgery and follow-up visit, one month later)
- Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption(In the 4 days following the hepatectomy)
- Immediate and late complications related to the perfusion, the medical device and other predictable side effects(In the 4 days following the hepatectomy and one month later)
- Evaluation of patients' perception of post-surgery pain(In the 4 days following the hepatectomy)
- Patients' satisfaction with the pain care(Four days after the hepatectomy)