Clinical trial NCT01194843: Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
Official title: A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatectomy
Pain
Metastasis
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Fondation Apicil
First posted: 2010-09-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.


Eligibility 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

Primary outcomes:
measure: Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption
timeFrame: In the 4 days following the hepatectomy
Secondary outcomes:
measure: Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption
timeFrame: In the 4 days following the hepatectomy
measure: Evaluation of patients' perception of post-surgery pain
timeFrame: In the 4 days following the hepatectomy
measure: Immediate and late complications related to the perfusion, the medical device and other predictable side effects
timeFrame: In the 4 days following the hepatectomy and one month later
measure: Patients' post-surgery rehabilitation
timeFrame: Between surgery and follow-up visit, one month later
measure: Patients' satisfaction with the pain care
timeFrame: Four days after the hepatectomy
Other outcomes:
Locations:
city: LYON Cedex 08
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Véronique Peres-Bachelot, MD
role: PRINCIPAL_INVESTIGATOR
References:
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