Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations (DPO)

Léon Bérard Center

Status

Completed

Conditions

Metastasis

Hepatectomy

Pain

Treatments

Drug: Physiological serum

Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01194843

ET2007-073 (Registry Identifier)

DPO-Hepatectomy

2007-007968-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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