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

This study is currently recruiting participants.
Verified January 2013 by University of California, Davis
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steve R. Martinez, MD, MAS, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00859157
First received: March 7, 2009
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Breast Cancer
Pain
Perioperative/Postoperative Complications
 Procedure: therapeutic conventional surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Post-operative pain at 1 and at 7-10 days after mastectomy [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of acetaminophen/oxycodone tablets taken [ Time Frame: 7-10 days after surgery ] [ Designated as safety issue: No ]
  • Total time of operation from breast incision to completion of wound closure [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Time of operation from first incision to completion of both superior and inferior skin flaps [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Estimated blood loss [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859157

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steve R. Martinez, MD University of California, Davis
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steve R. Martinez, MD, MAS, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00859157     History of Changes
Other Study ID Numbers: CDR0000633754, UCD-CCSO001, 200816282-1
Study First Received: March 7, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 13, 2013