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Trial record 8 of 9 for:    Recruiting, Not yet recruiting, Available Studies | "Electromagnetic Fields"

PEMF and PEC Blocks in Mastectomy Reconstruction Patients

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ClinicalTrials.gov Identifier: NCT03360214
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: Bupivacaine Hydrochloride Other: Placebo Drug Device: Pulsed Electromagnetic Field (PEMF) Device Other: Placebo Device Phase 4

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 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 block—the pectoral interfascial block (PIB) in which a long-lasting local anesthetic (bupivacaine) 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. Thus, the purpose of the proposed trial is a evaluate the efficacy of these two modalities of postoperative analgesia in patients undergoing mastectomy and tissue expander reconstruction.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active PEMF + Treatment PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride).
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

Active PEMF + Sham PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Other: Placebo Drug
For sham drug, 0.9% saline, will be used.
Other Name: Saline

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

Sham PEMF + Treatment PIB
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Drug: Bupivacaine Hydrochloride
For active drug, 0.25% marcaine, will be used.
Other Names:
  • Marcaine
  • 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.

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 narcotic medications
  • Intake of any chronic opioids or pain medications preoperatively

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360214


Contacts
Contact: Christine Rohde, MD 212-347-3707 chr2111@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christine H Rohde, MD    212-342-3707      
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Christine Rohde, MD Columbia University

Responsible Party: Christine Hsu Rohde, MD, Associate Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT03360214     History of Changes
Other Study ID Numbers: AAAQ4708
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Christine Hsu Rohde, MD, Columbia University:
Mastectomy
Tissue expander
PEMF
PIB

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents