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


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatectomy, Pain, Metastasis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption

Outcome Time Frame:

In the 4 days following the hepatectomy

Safety Issue:

No

Principal Investigator

Véronique Peres-Bachelot, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

DPO-Hepatectomy

NCT ID:

NCT01194843

Start Date:

March 2009

Completion Date:

May 2013

Related Keywords:

  • Hepatectomy
  • Pain
  • Metastasis
  • Neoplasm Metastasis

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