Chlorhydrate of Ropivacaine and Breast Cancer Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370240

Enrollment

260

Registered

2006-08-31

Start date

2006-09-30

Completion date

2008-11-30

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Pain,Postoperative

Keywords

Female, Anesthetics,local

Brief summary

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.

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.

Interventions

DRUGChlorhydrate de Ropivacaine

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

OTHERplacebo

The PCB group received saline solution in equal volume.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale	2 hours after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026