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Completed

NCT Number: NCT00370240

Chlorhydrate of Ropivacaine and Breast Cancer Surgery

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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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pain,Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

René Huguenin Center

Saint-Cloud, 92210, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhydrate de Ropivacaine

Drug

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

Placebo

Other

The PCB group received saline solution in equal volume.

Primary outcomes

  1. 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

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

    Time frame: 2 hours after surgery

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Collaborators

  • AstraZeneca
  • Gustave Roussy, Cancer Campus, Grand Paris

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Aug 31, 2006
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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