Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Institut Curie

Status and phase: Completed; Phase 4

Conditions: Breast Neoplasms; Pain,Postoperative

Treatments: Other: placebo; Drug: Chlorhydrate de Ropivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00370240

(CRH 05353A)

EudraCT 2005-005691-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups, including a placebo group

Ropivacaïne

Experimental group

Treatment:

Drug: Chlorhydrate de Ropivacaine

placebo

Placebo Comparator group

Treatment:

Other: placebo