PEMF and PEC Blocks in Mastectomy Reconstruction Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride
* Other: Placebo Drug
* Device: Pulsed Electromagnetic Field (PEMF) Device
* Other: Placebo Device
* Drug: Ropivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active PEMF + Treatment PIB<br>Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). | Drug: Bupivacaine Hydrochloride<br>* For active drug, 0.25% marcaine, will be used.<br>* Other names: PIB;Device: Pulsed Electromagnetic Field (PEMF) Device<br>* 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.<br>* Other names: Torino II;Drug: Ropivacaine Hydrochloride<br>* For active drug, 0.25% naropin, will be used.<br>* Other names: PIB;|
| Other: Active PEMF + Sham PIB<br>Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug. | Other: Placebo Drug<br>* For sham drug, 0.9% saline, will be used.<br>* Other names: Saline;Device: Pulsed Electromagnetic Field (PEMF) Device<br>* 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.<br>* Other names: Torino II;|
| Other: Sham PEMF + Treatment PIB<br>Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). | Drug: Bupivacaine Hydrochloride<br>* For active drug, 0.25% marcaine, will be used.<br>* Other names: PIB;Other: Placebo Device<br>* Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.<br>Drug: Ropivacaine Hydrochloride<br>* For active drug, 0.25% naropin, will be used.<br>* Other names: PIB;|
| Other: Sham PEMF + Sham PIB<br>Participants will receive placebo drug and placebo device. | Other: Placebo Drug<br>* For sham drug, 0.9% saline, will be used.<br>* Other names: Saline;Other: Placebo Device<br>* Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Visual Analog Scale (VAS) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastectomy, Tissue expander, PEMF, PIB