Chlorhydrate of Ropivacaine and Breast Cancer Surgery
Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.
2 other identifiers
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
August 31, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedSeptember 22, 2025
September 1, 2025
10 months
August 30, 2006
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.
3 months after surgery
Secondary Outcomes (1)
Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale
2 hours after surgery
Study Arms (2)
Ropivacaïne
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
- AstraZenecacollaborator
- Gustave Roussy, Cancer Campus, Grand Pariscollaborator
Study Sites (1)
René Huguenin Center
Saint-Cloud, 92210, France
Related Publications (1)
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.
PMID: 23340351RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aline H Albi-Feldzer, MD
Centre René Huguenin - Saint-Cloud - France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2006
First Posted
August 31, 2006
Study Start
September 1, 2006
Primary Completion
July 1, 2007
Study Completion
November 1, 2008
Last Updated
September 22, 2025
Record last verified: 2025-09