Status:
COMPLETED
Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
AstraZeneca
Fondation Apicil
Conditions:
Hepatectomy
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01194843
Start Date
March 1 2009
End Date
April 1 2015
Last Update
April 21 2015
Active Locations (1)
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1
Centre Léon Bérard
Lyon, France, 69373