Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Institut Curie260 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Breast Neoplasms Pain,Postoperative

Interventions

Chlorhydrate de RopivacaineDRUG

The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)

placeboOTHER

The PCB group received saline solution in equal volume.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

René Huguenin Center

Saint-Cloud, France

Outcomes

Primary Outcomes

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 Outcomes

Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale

Time frame: 2 hours after surgery

Data from ClinicalTrials.gov

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