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

This study is currently recruiting participants.
Verified January 2014 by Centre Leon Berard
Sponsor:
Collaborators:
AstraZeneca
Fondation Apicil
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01194843
First received: September 2, 2010
Last updated: January 30, 2014
Last verified: January 2014

September 2, 2010
January 30, 2014
March 2009
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01194843 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Hepatectomy
  • Pain
  • Metastasis
  • 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
  • Experimental: Ropivacaine
    Ropivacaine administration by local per and post surgery infiltration
    Intervention: Drug: Ropivacaine
  • Active Comparator: Physiological serum
    Administration of physiological serum by local per and post surgery infiltration
    Intervention: Drug: Physiological serum

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01194843
DPO-Hepatectomy, ET2007-073, 2007-007968-19
No
Centre Leon Berard
Centre Leon Berard
  • AstraZeneca
  • Fondation Apicil
Principal Investigator: Véronique Peres-Bachelot, MD Centre Léon Bérard
Centre Leon Berard
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP