Breast Cancer Clinical Trial
Official title:
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known
whether tumescent mastectomy or standard mastectomy results in less pain in women with
breast cancer.
PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain
after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
OBJECTIVES:
Primary
- To compare post-operative pain after tumescent vs standard mastectomy in women with
stage I-III breast cancer.
Secondary
- To compare the total time of operation from incision to completion of wound closure.
- To compare the time of operation from first incision to completion of skin flaps.
- To compare the total estimated blood loss.
- To compare the number of days the Jackson-Pratt drain is left in place under skin flaps
with wound drainage > 30 mL/24 hours.
- To compare the incidence of wound complications such as skin necrosis, hematoma,
cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and
treatment recommendations.
- Group 1: Patients undergo standard mastectomy.
- Group 2: Patients undergo tumescent mastectomy. All patients receive standardized
post-operative pain management comprising morphine sulfate for analgesia or an
equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients
then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a
comparable amount of another narcotic/acetaminophen combination) every 6 hours as
needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
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