Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer

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).

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

  • Invasive (ductal or lobular) breast cancer
  • In situ (ductal) breast cancer

• Stage 0-III disease

• Localized disease

• Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• WBC ≥ 1,500/mm^3
• Platelet count ≥ 90,000/mm^3
• PT/PTT ≤ upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• No NYHA cardiac disease class III-IV
• Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone
• Body Mass Index ≤ 40

PRIOR CONCURRENT THERAPY:

• No prior major breast surgery, including breast augmentation or reduction surgery
• No preoperative chemotherapy or radiotherapy
• No concurrent immediate breast reconstruction
• No concurrent bilateral mastectomy
• No concurrent narcotic pain medication