drugset / Trial / NCT02655965

Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

NCT02655965

Phase 3 Completed 54 enrolled Jules Bordet Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).

Timeline

Start
2016-05
Primary completion
2019-11
Completion
2021-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified 5 ug/ml Other
Subject Ropivacaine Other / unclassified 3.5 mg/ml Other

Indications

No indication recorded.