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Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.


Phase 4
18 Years
85 Years
Not Enrolling
Female
Breast Neoplasms, Pain,Postoperative

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Trial Information

Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.

Outcome Time Frame:

3 months after surgery

Safety Issue:

No

Principal Investigator

Aline H Albi-Feldzer, MD

Investigator Role:

Study Director

Investigator Affiliation:

Centre René Huguenin - Saint-Cloud - France

Authority:

France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

Study ID:

(CRH 05353A)

NCT ID:

NCT00370240

Start Date:

September 2006

Completion Date:

November 2008

Related Keywords:

  • Breast Neoplasms
  • Pain,Postoperative
  • Female
  • Anesthetics,local
  • Breast Neoplasms
  • Neoplasms
  • Pain, Postoperative

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