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

University of California (UC) Davis

Status

Completed

Conditions

Breast Cancer

Perioperative/Postoperative Complications

Pain

Treatments

Procedure: therapeutic conventional surgery

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00859157

246600

200816282

UCD-CCSO001

CDR0000633754 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment

74 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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