PEMF and PEC Blocks in Mastectomy Reconstruction Patients

March 7, 2022 updated by: Christine Hsu Rohde, MD, Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 all narcotic medications
  • Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Active PEMF + Treatment PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Drug: Bupivacaine Hydrochloride
For active drug, 0.25% marcaine, will be used.
Other Names:
  • Marcaine
  • PIB
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 Names:
  • Sofpulse
  • Torino II
Drug: Ropivacaine Hydrochloride
For active drug, 0.25% naropin, will be used.
Other Names:
  • Naropin
  • PIB
OTHER: Active PEMF + Sham PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
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 Names:
  • Sofpulse
  • Torino II
Other: Placebo Drug
For sham drug, 0.9% saline, will be used.
Other Names:
  • Saline
OTHER: Sham PEMF + Treatment PIB
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Drug: Bupivacaine Hydrochloride
For active drug, 0.25% marcaine, will be used.
Other Names:
  • Marcaine
  • PIB
Drug: Ropivacaine Hydrochloride
For active drug, 0.25% naropin, will be used.
Other Names:
  • Naropin
  • PIB
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.
OTHER: Sham PEMF + Sham PIB
Participants will receive placebo drug and placebo device.
Other: Placebo Drug
For sham drug, 0.9% saline, will be used.
Other Names:
  • Saline
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Visual Analog Scale (VAS)
Time Frame: Up to 2 years
Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery Questionnaires (QoR)
Time Frame: Up to 2 years
Quality of recovery will be measured using QoR. QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. Number "0" indicates none of the time and number "10" indicates all of the time.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2017

Primary Completion (ACTUAL)

March 7, 2022

Study Completion (ACTUAL)

March 7, 2022

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (ACTUAL)

December 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ4708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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