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Chlorhydrate of Ropivacaine and Breast Cancer Surgery

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Institut Gustave Roussy
Institut Curie
Information provided by (Responsible Party):
Centre Rene Huguenin
ClinicalTrials.gov Identifier:
NCT00370240
First received: August 30, 2006
Last updated: May 14, 2012
Last verified: July 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Centre Rene Huguenin:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale [ Time Frame: 2 hours after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370240

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

No publications provided

Responsible Party: Centre Rene Huguenin
ClinicalTrials.gov Identifier: NCT00370240     History of Changes
Other Study ID Numbers: (CRH 05353A), EudraCT 2005-005691-32
Study First Received: August 30, 2006
Last Updated: May 14, 2012
Health Authority: France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

Keywords provided by Centre Rene Huguenin:
Female
Anesthetics,local

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

ClinicalTrials.gov processed this record on June 18, 2013