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

Breast Cancer Clinical Trial

Official title:

Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859157
• Other study ID #: 246600
• Secondary ID: UCD-CCSO00120081
• Status: Completed
• Phase: N/A
• First received: March 7, 2009
• Last updated: June 19, 2017
• Start date: October 2008
• Est. completion date: January 2014

Study information

• Verified date: June 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pain
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• therapeutic conventional surgery
Patients undergo tumescent or standard mastectomy

Locations

Country	Name	City	State
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain at 1 and at 7-10 days after mastectomy		7-10 days
Secondary	Number of acetaminophen/oxycodone tablets taken		7-10 days after surgery
Secondary	Total time of operation from breast incision to completion of wound closure		Day of surgery
Secondary	Time of operation from first incision to completion of both superior and inferior skin flaps		Day of surgery
Secondary	Estimated blood loss		Day of surgery
Secondary	Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours		7-10 days after surgery
Secondary	Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively		Up to 10 days after surgery