NCT01194843

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatectomy
• Pain
• Metastasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-02-01
• Completion: 2015-04-01
• First posted: 2010-09-03
• Last updated: 2015-04-21

Locations

1 site across 1 country: France