Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

Not Applicable

Completed

• Conditions: Hepatectomy; Pain; Metastasis
• Interventions: Drug: Physiological serum; Drug: Ropivacaine

• Registration Number: NCT01194843
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Status Verified: 2014-01
• Primary Completion: 2014-02
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological serum	Physiological serum	Administration of physiological serum by local per and post surgery infiltration
Ropivacaine	Ropivacaine	Ropivacaine administration by local per and post surgery infiltration

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patients' post-surgery rehabilitation	Between surgery and follow-up visit, one month later
Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption	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
Evaluation of patients' perception of post-surgery pain	In the 4 days following the hepatectomy
Patients' satisfaction with the pain care	Four days after the hepatectomy

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 LYON Cedex 08, France