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PEMF and PEC Blocks in Mastectomy Reconstruction Patients

NCT03360214 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-15

Study results available
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Summary

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.

Conditions

  • Breast Cancer Female

Interventions

DRUG

Bupivacaine Hydrochloride

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

OTHER

Placebo Drug

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

DEVICE

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.

OTHER

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.

DRUG

Ropivacaine Hydrochloride

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

Sponsors & Collaborators

Principal Investigators

  • Christine Rohde, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2022-03-07
Completion
2022-03-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360214 on ClinicalTrials.gov