Trial Outcomes & Findings for PEMF and PEC Blocks in Mastectomy Reconstruction Patients (NCT NCT03360214)
NCT ID: NCT03360214
Last Updated: 2025-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
1 hour post-intervention
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
Active PEMF + Treatment PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used.
|
Active PEMF + Sham PIB
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
Sham PEMF + Treatment PIB
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
Baseline characteristics by cohort
| Measure |
Active PEMF + Treatment PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug: 0.25% Bupivacaine Hydrochloride or 0.25% Ropivacaine HCl.
|
Active PEMF + Sham PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug: 0.9% saline.
|
Sham PEMF + Treatment PIB
n=15 Participants
Participants will receive a placebo device (identical appearance to active device, but produces no electromagnetic field) and active drug: 0.25% Bupivacaine Hydrochloride.
|
Sham PEMF + Sham PIB
n=15 Participants
Participants will receive placebo drug and placebo device.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
53 years
n=7 Participants
|
48 years
n=5 Participants
|
53 years
n=4 Participants
|
50 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
15 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 hour post-interventionPopulation: 4 participants declined to do the VAS assessment.
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.
Outcome measures
| Measure |
Active PEMF + Treatment PIB
n=14 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used.
|
Active PEMF + Sham PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
Sham PEMF + Treatment PIB
n=13 Participants
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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
n=14 Participants
Participants will receive placebo drug and placebo device.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
|---|---|---|---|---|
|
Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention
|
6.64 score on a scale
Standard Deviation 2.76
|
6.67 score on a scale
Standard Deviation 2.29
|
4.62 score on a scale
Standard Deviation 3.57
|
6.93 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 3 weeks post-interventionPain 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.
Outcome measures
| Measure |
Active PEMF + Treatment PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used.
|
Active PEMF + Sham PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
Sham PEMF + Treatment PIB
n=15 Participants
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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
n=15 Participants
Participants will receive placebo drug and placebo device.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
|---|---|---|---|---|
|
Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention
|
2.53 score on a scale
Standard Deviation 2.07
|
2.00 score on a scale
Standard Deviation 2.20
|
2.00 score on a scale
Standard Deviation 1.89
|
2.67 score on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: 1 hour post-interventionPopulation: Some participants in each arm declined to do the QoR assessment.
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.
Outcome measures
| Measure |
Active PEMF + Treatment PIB
n=8 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used.
|
Active PEMF + Sham PIB
n=10 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
Sham PEMF + Treatment PIB
n=11 Participants
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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
n=12 Participants
Participants will receive placebo drug and placebo device.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
|---|---|---|---|---|
|
Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention
|
82.88 score on a scale
Standard Deviation 25.67
|
90.90 score on a scale
Standard Deviation 36.14
|
82.91 score on a scale
Standard Deviation 35.24
|
77.50 score on a scale
Standard Deviation 16.84
|
SECONDARY outcome
Timeframe: 3 weeks post-interventionPopulation: 1 participant declined to do the QoR assessment.
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.
Outcome measures
| Measure |
Active PEMF + Treatment PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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.
Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used.
|
Active PEMF + Sham PIB
n=15 Participants
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
Sham PEMF + Treatment PIB
n=15 Participants
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride).
Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used.
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
n=14 Participants
Participants will receive placebo drug and placebo device.
Placebo Drug: For sham drug, 0.9% saline, will be used.
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.
|
|---|---|---|---|---|
|
Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention
|
122 score on a scale
Standard Deviation 23.79
|
123.27 score on a scale
Standard Deviation 18.77
|
125.93 score on a scale
Standard Deviation 20.29
|
121 score on a scale
Standard Deviation 26.92
|
Adverse Events
Active PEMF + Bupivacaine Hydrochloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active PEMF + Ropivacaine HCl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active PEMF + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham PEMF + Bupivacaine Hydrochloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham PEMF + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place