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

Completed

• Conditions: Perioperative/Postoperative Complications; Breast Cancer; Pain
• Interventions: Procedure: therapeutic conventional surgery

• Registration Number: NCT00859157
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-07
• Study First Submitted QC: 2009-03-07
• Study First Posted: 2009-03-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	therapeutic conventional surgery	Patients undergo standard mastectomy.
Group 2	therapeutic conventional surgery	Patients undergo tumescent mastectomy.

Primary Outcome Measures

Name	Time	Method
Post-operative pain at 1 and at 7-10 days after mastectomy	7-10 days

Secondary Outcome Measures

Name	Time	Method
Number of acetaminophen/oxycodone tablets taken	7-10 days after surgery
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours	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
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively	Up to 10 days after surgery

Trial Locations

Locations (1)

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States