Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatectomy, Pain, Metastasis

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Physiological serum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Ropivacaine administration by local per and post surgery infiltration | Drug: Ropivacaine<br>* 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<br>|
| Active Comparator: Physiological serum<br>Administration of physiological serum by local per and post surgery infiltration | Drug: Physiological serum<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption |  | In the 4 days following the hepatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption |  | In the 4 days following the hepatectomy | 
| Evaluation of patients' perception of post-surgery pain |  | In the 4 days following the hepatectomy | 
| Immediate and late complications related to the perfusion, the medical device and other predictable side effects |  | In the 4 days following the hepatectomy and one month later | 
| Patients' post-surgery rehabilitation |  | Between surgery and follow-up visit, one month later | 
| Patients' satisfaction with the pain care |  | Four days after the hepatectomy |