This randomized phase IV trial studies how well pulsed electromagnetic fields therapy and pectoral interfascial block works in reducing pain after surgery in patients with breast cancer undergoing mastectomy and tissue expander reconstruction. Pulsed electromagnetic fields therapy is a device with a battery placed over dressings around the surgical site and creates small areas of magnetization without heat or sensation. A pectoral interfascial block is an injection of a long-lasting pain control medication called bupivacaine or ropivacaine into the area being operated on for pain control after surgery. Patients who receive either pulsed electromagnetic field therapy or a pectoral interfascial block may have a reduction in pain after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03360214.
PRIMARY OBJECTIVES:
I. To quantify the effect of pulsed electromagnetic field (PEMF) devices on postoperative pain in mastectomy + tissue expander patients.
II. To evaluate the effect of PEMF devices on postoperative narcotic requirements.
III. To compare the efficacy of PEMF versus (vs.) pectoral interfascial block (PIB) in the control of post-operative pain in mastectomy + tissue expander patients.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive bupivacaine or ropivacaine intramuscularly (IM) before surgery as a PIB and then undergo standard of care mastectomy and tissue expander reconstruction with standard post-operative pain medications as needed. Patients also undergo PEMF therapy with a PEMF device worn continuously for 7 days after surgery.
ARM II: Patients receive saline IM before surgery as a sham PIB and then undergo standard of care mastectomy and tissue expander reconstruction with standard post-operative pain medications as needed. Patients also undergo PEMF therapy with a PEMF device worn continuously for 7 days after surgery.
ARM III: Patients receive bupivacaine or ropivacaine IM before surgery as a PIB and then undergo standard of care mastectomy and tissue expander reconstruction with standard post-operative pain medications as needed. Patients also undergo sham PEMF therapy with a sham PEMF device worn continuously for 7 days after surgery.
ARM IV: Patients receive saline IM before surgery as a sham PIB and then undergo standard of care mastectomy and tissue expander reconstruction with standard post-operative pain medications as needed. Patients also undergo sham PEMF therapy with a sham PEMF device worn continuously for 7 days after surgery.
After completion of the study, patients are followed up at 1 and 3 weeks.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorChristine Rohde
