CompletedPhase 4

PEMF and PEC Blocks in Mastectomy Reconstruction Patients

United States60 participantsStarted 2017-07-05

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention

Timeframe: 1 hour post-intervention

Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention

Timeframe: 3 weeks post-intervention

Trial details

NCT IDNCT03360214

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-07

Results submitted2023-03-10

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