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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique

Conditions
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Breast Cancer, Pain, Perioperative/Postoperative Complications

Intervention / Treatment
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* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients undergo standard mastectomy. | Procedure: therapeutic conventional surgery<br>* Patients undergo tumescent or standard mastectomy<br>|
| Group 2<br>Patients undergo tumescent mastectomy. | Procedure: therapeutic conventional surgery<br>* Patients undergo tumescent or standard mastectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain at 1 and at 7-10 days after mastectomy |  | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acetaminophen/oxycodone tablets taken |  | 7-10 days after surgery | 
| Total time of operation from breast incision to completion of wound closure |  | Day of surgery | 
| Time of operation from first incision to completion of both superior and inferior skin flaps |  | Day of surgery | 
| Estimated blood loss |  | Day of surgery | 
| Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours |  | 7-10 days after surgery | 
| Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively |  | Up to 10 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative/postoperative complications, pain, ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer