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

NCT ID: NCT00859157

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-01-31

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).

Conditions

Breast Cancer; Pain; Perioperative/Postoperative Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Patients undergo standard mastectomy.

therapeutic conventional surgery

Intervention Type: PROCEDURE

Patients undergo tumescent or standard mastectomy

Group 2

Patients undergo tumescent mastectomy.

therapeutic conventional surgery

Intervention Type: PROCEDURE

Patients undergo tumescent or standard mastectomy

Interventions

therapeutic conventional surgery

Patients undergo tumescent or standard mastectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve R. Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Cancer Center

Sacramento, California, United States

Countries

United States

Other Identifiers

UCD-CCSO001

Identifier Type: -

Identifier Source: secondary_id

200816282

Identifier Type: -

Identifier Source: secondary_id

CDR0000633754

Identifier Type: OTHER

Identifier Source: secondary_id

246600

Identifier Type: -

Identifier Source: org_study_id