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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Breast Cancer; Pain; Perioperative/Postoperative Complications	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 Design

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Study Type :	Observational
Actual Enrollment :	74 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
Study Start Date :	October 2008
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Post-operative pain at 1 and at 7-10 days after mastectomy [ Time Frame: 7-10 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

University of California, Davis

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Steve R. Martinez, MD	University of California, Davis

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00859157 History of Changes
Other Study ID Numbers:	246600; UCD-CCSO001; 200816282; CDR0000633754 ( Other Identifier: UC Davis )
First Posted:	March 10, 2009
Last Update Posted:	June 21, 2017
Last Verified:	June 2017

Keywords provided by University of California, Davis:

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

Additional relevant MeSH terms:

Breast Neoplasms; Postoperative Complications; Neoplasms by Site; Neoplasms	Breast Diseases; Skin Diseases; Pathologic Processes