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Completed

NCT Number: NCT01194843

Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

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.

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Key information

Conditions

Hepatectomy Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

physiological serum

Drug

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

Primary outcomes

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

    Time frame: In the 4 days following the hepatectomy

Secondary outcomes

  1. 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

  2. Evaluation of patients' perception of post-surgery pain

    Time frame: In the 4 days following the hepatectomy

  3. 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

  4. Patients' post-surgery rehabilitation

    Time frame: Between surgery and follow-up visit, one month later

  5. Patients' satisfaction with the pain care

    Time frame: Four days after the hepatectomy

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • AstraZeneca
  • Fondation Apicil

Registry information

Official study title

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

Acronym: DPO

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Sep 3, 2010
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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