PEMF and PEC Blocks in Mastectomy Reconstruction Patients



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:July 5, 2017
End Date:December 31, 2019
Contact:Christine Rohde, MD
Email:chr2111@cumc.columbia.edu
Phone:212-347-3707

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A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction

This is a prospective randomized controlled double-blind interventional study comparing the
effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and
placebo on postoperative pain control. This study has the interdisciplinary cooperation of
the regional anesthesia group, and the breast and plastic surgery divisions. All female
patients with breast cancer evaluated at Columbia University Medical Center (CUMC) who are
undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be
offered enrollment in this prospective study.

Chronic pain after mastectomy, or breast tissue removal, is very common with almost half of
women experiencing some type of residual pain and even 13% characterizing it as severe. Poor
acute postoperative pain control is not only associated with development of chronic pain, but
has also been shown to be associated with delayed wound healing. Therefore, optimization of
postoperative pain control is paramount not just for patient comfort, but to decrease
immediate and long-term postoperative complications.

There are two adjunctive modes of perioperative pain control currently in use at CUMC. The
first mode uses pulsed electromagnetic fields (PEMF) and consists of a noninvasive device
placed over dressings around the surgical site. The second is a regional anesthetic block—the
pectoral interfascial block (PIB) in which a long-lasting local anesthetic (bupivacaine) is
injected into the surgical dissection area. Both of these techniques for postoperative
analgesia have been shown to be effective in different types of breast surgery, but there is
no current literature comparing the two modalities in their efficacy in reducing
postoperative pain. There is also no current literature in their efficacy in the mastectomy
and tissue expander patient population. Thus, the purpose of the proposed trial is a evaluate
the efficacy of these two modalities of postoperative analgesia in patients undergoing
mastectomy and tissue expander reconstruction.

Inclusion Criteria:

- Subjects must be female

- Subjects must be 18 years or older

- Subjects must be undergoing unilateral or bilateral mastectomy with tissue expander
reconstruction

Exclusion Criteria:

- Allergy to narcotic medications

- Intake of any chronic opioids or pain medications preoperatively
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Phone: 212-342-3707
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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