A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management
Overview
- Phase
- Not Applicable
- Intervention
- Ropivacaine
- Conditions
- Hepatectomy
- Sponsor
- Centre Leon Berard
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility 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
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
Arms & Interventions
Ropivacaine
Ropivacaine administration by local per and post surgery infiltration
Intervention: Ropivacaine
Physiological serum
Administration of physiological serum by local per and post surgery infiltration
Intervention: Physiological serum
Outcomes
Primary Outcomes
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
- Patients' post-surgery rehabilitation(Between surgery and follow-up visit, one month later)
- Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption(In the 4 days following the hepatectomy)
- Immediate and late complications related to the perfusion, the medical device and other predictable side effects(In the 4 days following the hepatectomy and one month later)
- Evaluation of patients' perception of post-surgery pain(In the 4 days following the hepatectomy)
- Patients' satisfaction with the pain care(Four days after the hepatectomy)