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

This study is currently recruiting participants.
Verified June 2012 by Centre Leon Berard
Sponsor:
Collaborators:
AstraZeneca
Apicil
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01194843
First received: September 2, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Hepatectomy
Pain
Metastasis
 Drug: Ropivacaine
Drug: Physiological serum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption [ Time Frame: In the 4 days following the hepatectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of patients' perception of post-surgery pain [ Time Frame: In the 4 days following the hepatectomy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patients' post-surgery rehabilitation [ Time Frame: Between surgery and follow-up visit, one month later ] [ Designated as safety issue: No ]
  • Patients' satisfaction with the pain care [ Time Frame: Four days after the hepatectomy ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194843

Contacts
Contact: Ellen Blanc +33 478 78 29 67 ellen.blanc@lyon.unicancer.fr
Contact: Justine Semal +33 478 78 29 22 justine.semal@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
LYON Cedex 08, France, 69373
Principal Investigator: Véronique Peres-Bachelot, MD            
Sub-Investigator: Hervé Rosay, MD            
Sub-Investigator: Jean-Edgard Mazères, MD            
Sub-Investigator: Patrick Bachmann, MD            
Sub-Investigator: Henri Sebban, MD            
Sub-Investigator: Stéphanie Pouderoux, MD            
Sub-Investigator: Fabienne Montange, MD            
Sub-Investigator: Pierre Meeus, MD            
Sub-Investigator: Michel Rivoire, MD            
Sub-Investigator: Anne-Laure Daunizeau, MD            
Sub-Investigator: Georges Romero, MD            
Sub-Investigator: Patrice PEYRAT, MD            
Sub-Investigator: Henri-Jacques CLEMENT, MD            
Sponsors and Collaborators
Centre Leon Berard
AstraZeneca
Apicil
Investigators
Principal Investigator: Véronique Peres-Bachelot, MD Centre Léon Bérard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01194843     History of Changes
Other Study ID Numbers: DPO-Hepatectomy, ET2007-073, 2007-007968-19
Study First Received: September 2, 2010
Last Updated: June 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013