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Clinical Trials/NCT00370240
NCT00370240
Completed
Phase 4

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

Institut Curie1 site in 1 country260 target enrollmentSeptember 1, 2006
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ConditionsBreast NeoplasmsPain,Postoperative
InterventionsChlorhydrate de Ropivacaineplacebo
DrugsChlorhydrate de Ropivacaine

Overview

Phase
Phase 4
Intervention
Chlorhydrate de Ropivacaine
Conditions
Breast Neoplasms
Sponsor
Institut Curie
Enrollment
260
Locations
1
Primary Endpoint
Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.
Status
Completed
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2006
End Date
November 1, 2008
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Ropivacaïne

Intervention: Chlorhydrate de Ropivacaine

placebo

Intervention: placebo

Outcomes

Primary Outcomes

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

  • Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale(2 hours after surgery)

Study Sites (1)

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