Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms Pain,Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ropivacaïne

Group Type EXPERIMENTAL

Chlorhydrate de Ropivacaine

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

The PCB group received saline solution in equal volume.

Interventions

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Chlorhydrate de Ropivacaine

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

Intervention Type DRUG

placebo

The PCB group received saline solution in equal volume.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No