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Completed

NCT Number: NCT03360214

PEMF and PEC Blocks in Mastectomy Reconstruction Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine Hydrochloride

Drug

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

Other names: Marcaine, PIB

Placebo drug

Other

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

Other names: Saline

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.

Other names: Sofpulse, Torino II

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.

Ropivacaine hydrochloride

Drug

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

Other names: Naropin, PIB

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2017
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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