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Chlorhydrate of Ropivacaine and Breast Cancer Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370240
First Posted: August 31, 2006
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
AstraZeneca
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Institut Curie
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Pain,Postoperative Drug: Chlorhydrate de Ropivacaine Other: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups. [ Time Frame: 3 months after surgery ]

Secondary Outcome Measures:
  • Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale [ Time Frame: 2 hours after surgery ]

Enrollment: 260
Study Start Date: September 2006
Study Completion Date: November 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaïne Drug: Chlorhydrate de Ropivacaine
The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)
Placebo Comparator: placebo Other: placebo
The PCB group received saline solution in equal volume.

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 ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370240


Locations
France
René Huguenin Center
Saint-Cloud, France, 92210
Sponsors and Collaborators
Institut Curie
AstraZeneca
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Director: Aline H Albi-Feldzer, MD Centre René Huguenin - Saint-Cloud - France
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT00370240     History of Changes
Other Study ID Numbers: (CRH 05353A)
EudraCT 2005-005691-32
First Submitted: August 30, 2006
First Posted: August 31, 2006
Last Update Posted: May 15, 2012
Last Verified: July 2007

Keywords provided by Institut Curie:
Female
Anesthetics,local

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents