CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Bupivacaine Hydrochloride +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03360214
NCT03360214Phase 4Completed
CompareCT.gov

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

Columbia University·interventional·Posted Dec 4, 2017·Updated Jun 15, 2025

In Brief

A Phase 4 clinical trial evaluating Bupivacaine Hydrochloride, Placebo Drug, and 3 other interventions for Breast Cancer Female. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer Female
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 4, 2017
Enrollment StartJul 5, 2017
Primary CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.6 years ago

Interventions

Bupivacaine Hydrochloridedrug

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

Placebo Drugother

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

Pulsed Electromagnetic Field (PEMF) Devicedevice

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.

Placebo Deviceother

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

Ropivacaine Hydrochloridedrug

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