Clinical trial NCT00859157: Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Official title: Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pain
Perioperative/Postoperative Complications
Keywords: 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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-10
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.

Brief summary: 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: 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).

Eligibility 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

Primary outcomes:
measure: Post-operative pain at 1 and at 7-10 days after mastectomy
timeFrame: 7-10 days
Secondary outcomes:
measure: Number of acetaminophen/oxycodone tablets taken
timeFrame: 7-10 days after surgery
measure: Total time of operation from breast incision to completion of wound closure
timeFrame: Day of surgery
measure: Time of operation from first incision to completion of both superior and inferior skin flaps
timeFrame: Day of surgery
measure: Estimated blood loss
timeFrame: Day of surgery
measure: Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
timeFrame: 7-10 days after surgery
measure: Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
timeFrame: Up to 10 days after surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Steve R. Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: