CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Ropivacaine +1 moredrug
Likely dose
Ropivacaine 40 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01194843
NCT01194843N/ACompleted

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

Centre Leon Berard·interventional·Posted Sep 3, 2010·Updated Apr 21, 2015

In Brief

A clinical study evaluating Ropivacaine and Physiological serum for Hepatectomy and 2 related conditions. Completed, enrolled 85 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2010
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 15.8 years ago

Interventions

Ropivacainedrug

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 serumdrug

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