Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborators: AstraZeneca; Fondation Apicil
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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