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

April 20, 2015 updated by: Centre Leon Berard

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LYON Cedex 08, France, 69373
        • Centre Léon Bérard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine
Ropivacaine administration by local per and post surgery infiltration
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
Active Comparator: Physiological serum
Administration of physiological serum by local per and post surgery infiltration
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

AstraZeneca
Fondation Apicil

Investigators

  • Principal Investigator: Véronique Peres-Bachelot, MD, Centre Léon Bérard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPO-Hepatectomy
  • ET2007-073 (Registry Identifier: Centre Léon Bérard)
  • 2007-007968-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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