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

Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Cancer; Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: therapeutic conventional surgery

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).

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients undergo standard mastectomy.	Procedure: therapeutic conventional surgery; Patients undergo tumescent or standard mastectomy
Group 2; Patients undergo tumescent mastectomy.	Procedure: therapeutic conventional surgery; Patients undergo tumescent or standard mastectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steve R. Martinez, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 7, 2009
• First Submitted That Met QC Criteria: March 7, 2009
• First Posted (Estimate): March 10, 2009

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage IIIB breast cancer; pain; stage II breast cancer; stage IA breast cancer; stage IB breast cancer; ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; perioperative/postoperative complications
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Postoperative Complications
• Other Study ID Numbers: 246600; UCD-CCSO001; 200816282; CDR0000633754 (Other Identifier: UC Davis)