Breast Cancer FemalePhase 4NCT03360214

PEMF and PEC Blocks in Mastectomy Reconstruction Patients

A Phase 4 study testing Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device and Ropivacaine Hydrochloride in people with Breast Cancer Female, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female
What is being tested?: Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device and Ropivacaine Hydrochloride
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2017to 7 Mar 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Breast Cancer Female
Being tested: Bupivacaine Hydrochloride, Placebo Drug, Pulsed Electromagnetic Field (PEMF) Device, Placebo Device, Ropivacaine Hydrochloride
Keywords: Mastectomy, Tissue expander, PEMF, PIB

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine HydrochlorideDrug
Also called Marcaine, PIB
For active drug, 0.25% marcaine, will be used.
Placebo DrugOther
Also called Saline
For sham drug, 0.9% saline, will be used.
Pulsed Electromagnetic Field (PEMF) DeviceDevice
Also called Sofpulse, Torino II
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
Also called Naropin, PIB
For active drug, 0.25% naropin, will be used.

Study groups in NCT03360214
Study group	Role	What they receive
Active PEMF + Treatment PIB	Other	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). Receives: 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. Receives: 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). Receives: Drug: Bupivacaine Hydrochloride; Other: Placebo Device; Drug: Ropivacaine Hydrochloride
Sham PEMF + Sham PIB	Other	Participants will receive placebo drug and placebo device. Receives: Other: Placebo Drug; Other: Placebo Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 weeks post-intervention

Secondary outcomes (2)

Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Measured: 1 hour post-intervention
Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Measured: 3 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 20177 Mar 2022

First posted4 Dec 2017
Study start5 Jul 2017
Primary completion7 Mar 2022
Study completion7 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360214
Sponsor's protocol ID: AAAQ4708
Status last verified: May 2025
First submitted: 27 Nov 2017
Last updated: 15 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction
ClinicalTrials.gov ID: NCT03360214
Acronym / sponsor ID: AAAQ4708
Conditions: Breast Cancer Female
Keywords: Mastectomy, Tissue expander, PEMF, PIB
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: 5 Jul 2017 (actual)
Primary completion: 7 Mar 2022 (actual)
Study completion: 7 Mar 2022 (actual)
First posted: 4 Dec 2017 (actual)
Results: Posted 15 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Active PEMF + Treatment PIB	Other	Drug: Bupivacaine Hydrochloride, Device: Pulsed Electromagnetic Field (PEMF) Device, Drug: Ropivacaine HydrochlorideParticipants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Active PEMF + Sham PIB	Other	Other: Placebo Drug, Device: Pulsed Electromagnetic Field (PEMF) DeviceParticipants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Sham PEMF + Treatment PIB	Other	Drug: Bupivacaine Hydrochloride, Other: Placebo Device, Drug: Ropivacaine HydrochlorideParticipants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Sham PEMF + Sham PIB	Other	Other: Placebo Drug, Other: Placebo DeviceParticipants will receive placebo drug and placebo device.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine HydrochlorideAlso: Marcaine, PIBFor active drug, 0.25% marcaine, will be used.	Drug	Active PEMF + Treatment PIB, Sham PEMF + Treatment PIB
Placebo DrugAlso: SalineFor sham drug, 0.9% saline, will be used.	Other	Active PEMF + Sham PIB, Sham PEMF + Sham PIB
Pulsed Electromagnetic Field (PEMF) DeviceAlso: Sofpulse, Torino IIThe 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.	Device	Active PEMF + Sham PIB, Active PEMF + Treatment PIB
Placebo DeviceSham 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, Sham PEMF + Treatment PIB
Ropivacaine HydrochlorideAlso: Naropin, PIBFor active drug, 0.25% naropin, will be used.	Drug	Active PEMF + Treatment PIB, Sham PEMF + Treatment PIB

Primary outcome

Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention
Time frame: 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.
Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention
Time frame: 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.

2 secondary outcomes

Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention
Time frame: 1 hour post-intervention
Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention
Time frame: 3 weeks post-intervention

Results and safety

Results posted to the registry on 15 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active PEMF + Treatment PIB	15	15
Active PEMF + Sham PIB	15	15
Sham PEMF + Treatment PIB	15	15
Sham PEMF + Sham PIB	15	15

Primary outcome: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention

Time frame: 1 hour post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Active PEMF + Treatment PIB n = 14	Active PEMF + Sham PIB n = 15	Sham PEMF + Treatment PIB n = 13	Sham PEMF + Sham PIB n = 14
Value	6.64 (2.76)	6.67 (2.29)	4.62 (3.57)	6.93 (2.4)

Population analysed: 4 participants declined to do the VAS assessment.

Primary outcome: Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention

Time frame: 3 weeks post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Active PEMF + Treatment PIB n = 15	Active PEMF + Sham PIB n = 15	Sham PEMF + Treatment PIB n = 15	Sham PEMF + Sham PIB n = 15
Value	2.53 (2.07)	2.00 (2.20)	2.00 (1.89)	2.67 (2.89)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active PEMF + Bupivacaine Hydrochloride	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Active PEMF + Ropivacaine HCl	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Active PEMF + Placebo	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sham PEMF + Bupivacaine Hydrochloride	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sham PEMF + Placebo	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Rohde, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention (time frame: 1 hour post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.