Trial | NCT01194843  Report issue

Title

Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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.
Study Started
Mar 31
2009
Primary Completion
Feb 28
2014
Study Completion
Apr 30
2015
Last Update
Apr 21
2015
Estimate

Drug Ropivacaine

40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy

Drug Physiological serum

40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy

Ropivacaine Experimental

Ropivacaine administration by local per and post surgery infiltration

Physiological serum Active Comparator

Administration of physiological serum by local per and post surgery infiltration

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
No Results Posted