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Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

NCT01194843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2015-04-21

No results posted yet for this study

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.

Conditions

  • Hepatectomy
  • Pain
  • Metastasis

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Fondation Apicil

    collaborator OTHER

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Véronique Peres-Bachelot, MD · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-02-28
Completion
2015-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194843 on ClinicalTrials.gov