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Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Primary Purpose

Breast Neoplasms, Pain,Postoperative

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Chlorhydrate de Ropivacaine
placebo
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Female, Anesthetics,local

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • René Huguenin Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaïne

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2006
Last Updated
November 2, 2017
Sponsor
Institut Curie
Collaborators
AstraZeneca, Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00370240
Brief Title
Chlorhydrate of Ropivacaine and Breast Cancer Surgery
Official Title
Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
Collaborators
AstraZeneca, Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Pain,Postoperative
Keywords
Female, Anesthetics,local

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaïne
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chlorhydrate de Ropivacaine
Intervention Description
The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
The PCB group received saline solution in equal volume.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale
Time Frame
2 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline H Albi-Feldzer, MD
Organizational Affiliation
Centre René Huguenin - Saint-Cloud - France
Official's Role
Study Director
Facility Information:
Facility Name
René Huguenin Center
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France

12. IPD Sharing Statement

Learn more about this trial

Chlorhydrate of Ropivacaine and Breast Cancer Surgery

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