Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Phase 4 Completed 260 enrolled Institut Curie AstraZeneca · collab Gustave Roussy, Cancer Campus, Grand Paris · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

Timeline

Start: 2006-09
Primary completion: 2007-07
Completion: 2008-11

Outcome

Missed primary endpoint

paper did not decrease chronic pain at 3 months (primary endpoint) PMID 23340351 ↗

paper At 3 months, the incidence of chronic pain was 33% and 27% (P = 0.37) in the ropivacaine and placebo groups, respectively. PMID 23340351 ↗

Publications

Results Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ropivacaine	Other / unclassified	0.375 %	Other
Subject	Ropivacaine	Other / unclassified	3 mg/kg	Other