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CompletedNCT00370240Updated Sep 22, 2025

Chlorhydrate of Ropivacaine and Breast Cancer Surgery

A Phase 4 interventional study of Chlorhydrate de Ropivacaine and placebo in Breast Neoplasms and Pain,Postoperative, sponsored by Institut Curie. Completed at 1 site in France. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Institut Curie · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Neoplasms
  • Pain,Postoperative

Keywords

  • Female
  • Anesthetics,local
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 260 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
260 participants (actual)

Study arms

  • Experimental
    Ropivacaïne

    Drug: Chlorhydrate de Ropivacaine

  • Placebo comparator
    placebo

    Other: placebo

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.

06

What researchers measure

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

07

Study locations

1 site
  • René Huguenin Center
    Saint-Cloud, 92210, France
08

References and documents

Publications

  • Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8. PubMed 23340351 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00370240
Lead sponsor
Institut Curie
Collaborators
AstraZeneca, Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Aug 31, 2006
Start date
Sep 2006
Primary completion
Jul 2007
Completion
Nov 2008
Last update
Sep 22, 2025

Study contacts

Aline H Albi-Feldzer, MD
study director · Centre René Huguenin - Saint-Cloud - France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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