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Surgery: Reconstruction

Nipple-Sparing Mastectomy

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy (NCT01002014)

Summary

Many women choose to have a skin-sparing mastectomy when they have immediate breast reconstruction. During a traditional skin-sparing mastectomy, all of the breast skin is preserved, except for the nipple and areola. Nipple-sparing mastectomy is a procedure that allows women to keep their nipple and areola as well. The goal of this study is to observe the cosmetic outcomes, patient satisfaction, and complications of nipple-sparing mastectomy. To be eligible, women must be planning to have either a therapeutic or prophylactic mastectomy.

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Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

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Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial

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