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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. (see Contacts and Locations)
Verified January 2013 by University of California, Davis
Sponsor:
Collaborator:
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

March 7, 2009
January 15, 2013
October 2008
December 2013   (final data collection date for primary outcome measure)
Post-operative pain at 1 and at 7-10 days after mastectomy [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
Post-operative pain at 1 and at 7-10 days after mastectomy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00859157 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of acetaminophen/oxycodone tablets taken [ Designated as safety issue: No ]
  • Total time of operation from breast incision to completion of wound closure [ Designated as safety issue: No ]
  • Time of operation from first incision to completion of both superior and inferior skin flaps [ Designated as safety issue: No ]
  • Estimated blood loss [ Designated as safety issue: No ]
  • Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours [ Designated as safety issue: No ]
  • Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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).
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.

  • Breast Cancer
  • Pain
  • Perioperative/Postoperative Complications
Procedure: therapeutic conventional surgery
Patients undergo tumescent or standard mastectomy
  • Group 1
    Patients undergo standard mastectomy.
    Intervention: Procedure: therapeutic conventional surgery
  • Group 2
    Patients undergo tumescent mastectomy.
    Intervention: Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT00859157
CDR0000633754, UCD-CCSO001, 200816282-1
No
Steve R. Martinez, MD, MAS, University of California, Davis
University of California, Davis
National Cancer Institute (NCI)
Principal Investigator: Steve R. Martinez, MD University of California, Davis
University of California, Davis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP