PEMF and PEC Blocks in Mastectomy Reconstruction Patients

NCT03360214 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 1 other identifier: AAAQ4708
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mastectomy; Tissue expander; PEMF; PIB

Outcome Measures

Primary Outcomes (2)

• Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention

  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.

  1 hour post-intervention

• Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention

  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.

  3 weeks post-intervention

Secondary Outcomes (2)

• Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention

  1 hour post-intervention

• Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention

  3 weeks post-intervention

Study Arms (4)

Active PEMF + Treatment PIB

OTHER

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

Drug: Bupivacaine Hydrochloride; Device: Pulsed Electromagnetic Field (PEMF) Device; Drug: Ropivacaine Hydrochloride

Active PEMF + Sham PIB

OTHER

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.

Other: Placebo Drug; Device: Pulsed Electromagnetic Field (PEMF) Device

Sham PEMF + Treatment PIB

OTHER

Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

Drug: Bupivacaine Hydrochloride; Other: Placebo Device; Drug: Ropivacaine Hydrochloride

Sham PEMF + Sham PIB

OTHER

Participants will receive placebo drug and placebo device.

Other: Placebo Drug; Other: Placebo Device

Interventions

Bupivacaine Hydrochloride DRUG

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

Also known as: Marcaine, PIB

Active PEMF + Treatment PIB; Sham PEMF + Treatment PIB

Placebo Drug OTHER

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

Also known as: Saline

Active PEMF + Sham PIB; Sham PEMF + Sham PIB

Pulsed Electromagnetic Field (PEMF) Device 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.

Also known as: Sofpulse, Torino II

Active PEMF + Sham PIB; Active PEMF + Treatment PIB

Placebo Device OTHER

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

Sham PEMF + Sham PIB; Sham PEMF + Treatment PIB

Ropivacaine Hydrochloride DRUG

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

Also known as: Naropin, PIB

Active PEMF + Treatment PIB; Sham PEMF + Treatment PIB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be female
• Subjects must be 18 years or older
• Subjects must be undergoing unilateral or bilateral mastectomy with tissue expander reconstruction

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Due to drug shortage, Ropivacaine was used in place of Bupivacaine in 1 participant. Bupivacaine and Ropivacaine are FDA-approved local anesthetics currently used in pectoral interfascial blocks for breast surgery patients. Bupivacaine and Ropivacaine are both long-acting local anesthetics with a similar mechanism of action.

Results Point of Contact

• Title: Sherene Ishtihar
• Organization: Columbia University

si2271@cumc.columbia.edu

212-342-3681

Study Officials

• Christine Rohde, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: July 5, 2017
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)