Chlorhydrate of Ropivacaine and Breast Cancer Surgery

September 17, 2025 updated by: Institut Curie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Cloud, France, 92210
        • René Huguenin Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
The PCB group received saline solution in equal volume.
Experimental: Ropivacaïne
Drug: Chlorhydrate de Ropivacaine
The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 3 months after surgery
3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Collaborators

AstraZeneca
Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Study Director: Aline H Albi-Feldzer, MD, Centre René Huguenin - Saint-Cloud - France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimated)

August 31, 2006

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (CRH 05353A)
  • EudraCT 2005-005691-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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