PEMF and PEC Blocks in Mastectomy Reconstruction Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2022-03-07

Brief Summary

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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.

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Detailed Description

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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 Columbia University Medical Center (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 and -the pectoral interfascial block (PIB) in which a long-lasting local anesthetic (bupivacaine/ropivacaine) 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. The proposed trial is a prospective, randomized, controlled, double-blind trial to evaluate the efficacy of these two modalities of postoperative analgesia in patients undergoing mastectomy and tissue expander reconstruction.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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Bupivacaine Hydrochloride

For active drug, 0.25% marcaine, will be used.

Intervention Type DRUG

Placebo Drug

For sham drug, 0.9% saline, will be used.

Intervention Type OTHER

Pulsed Electromagnetic Field (PEMF) Device

The pulsed electromagnetic field signal will consist of a 2-m sec burst of 27.12 megahertz (MHz) radiofrequency sinusoidal waves repeating at 2 bursts/second.

Intervention Type DEVICE

Placebo Device

Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.

Intervention Type OTHER

Ropivacaine Hydrochloride

For active drug, 0.25% naropin, will be used.

Intervention Type DRUG

Other Intervention Names

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Marcaine PIB Saline Sofpulse Torino II Naropin PIB

Eligibility Criteria

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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