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).
Study Type
OBSERVATIONAL
Enrollment
74
Patients undergo tumescent or standard mastectomy
University of California Davis Cancer Center
Sacramento, California, United States
Post-operative pain at 1 and at 7-10 days after mastectomy
Time frame: 7-10 days
Number of acetaminophen/oxycodone tablets taken
Time frame: 7-10 days after surgery
Total time of operation from breast incision to completion of wound closure
Time frame: Day of surgery
Time of operation from first incision to completion of both superior and inferior skin flaps
Time frame: Day of surgery
Estimated blood loss
Time frame: Day of surgery
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Time frame: 7-10 days after surgery
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
Time frame: Up to 10 days after surgery
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