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Wound Infiltration and Breast Cancer Surgery

NCT01404377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-07-28

No results posted yet for this study

Summary

Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

Conditions

Interventions

PROCEDURE

infiltration with ropivacaine solution

Patients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision.

Sponsors & Collaborators

  • Tenon Hospital, Paris

    lead OTHER

Principal Investigators

  • Francis Bonnet, MD · Tenon Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404377 on ClinicalTrials.gov