Phase 4
Completed N=60
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
Breast Cancer Female
Source: ClinicalTrials.gov NCT03360214 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention — 6.64; 6.67; 4.62; 6.93 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention |
6.64; 6.67; 4.62; 6.93 | — |
| PRIMARY Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention |
2.53; 2.00; 2.00; 2.67 | — |
| SECONDARY Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention |
82.88; 90.90; 82.91; 77.50 | — |
| SECONDARY Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention |
122; 123.27; 125.93; 121 | — |
Eligibility 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 all narcotic medications
- Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.
Data sourced from ClinicalTrials.gov (NCT03360214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.