Status:
COMPLETED
Chlorhydrate of Ropivacaine and Breast Cancer Surgery
Lead Sponsor:
Institut Curie
Collaborating Sponsors:
AstraZeneca
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Breast Neoplasms
Pain,Postoperative
Eligibility:
FEMALE
18-85 years
Phase:
PHASE4
Brief 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.
Detailed Description
An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivaca...
Eligibility Criteria
Inclusion
- Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy.
- ASA physical status 1, 2 or 3
- With a minimum life expectancy of 2 years
- Written informed consent
Exclusion
- Any previous cancer other than breast cancer
- Allergies to local anesthesic and morphine
- Reported history of drug
- Pregnancy
- Homolateral breast surgery during the last 3 years
- Analgesic use pre-operatively
- Renal, pulmonary or liver major dysfunction
- Active malignant disease
- Unable to follow the protocol for any reason
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00370240
Start Date
September 1 2006
End Date
November 1 2008
Last Update
September 22 2025
Active Locations (1)
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1
René Huguenin Center
Saint-Cloud, France, 92210