PEMF and PEC Blocks in Mastectomy Reconstruction Patients
A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Active PEMF + Treatment PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
|
For active drug, 0.25% marcaine, will be used.
Other Names:
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:
For active drug, 0.25% naropin, will be used.
Other Names:
|
|
Other: Active PEMF + Sham PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
|
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:
For sham drug, 0.9% saline, will be used.
Other Names:
|
|
Other: Sham PEMF + Treatment PIB
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
|
For active drug, 0.25% marcaine, will be used.
Other Names:
For active drug, 0.25% naropin, will be used.
Other Names:
Sham 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
Participants will receive placebo drug and placebo device.
|
For sham drug, 0.9% saline, will be used.
Other Names:
Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 hour post-intervention
|
|
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.
|
3 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 hour post-intervention
|
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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.
|
3 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Rohde, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ4708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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