NCT00859157

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	therapeutic conventional surgery	Patients undergo tumescent or standard mastectomy

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2009-03-10
• Last updated: 2017-06-21

Locations

1 site across 1 country: United States