PEMF and PEC Blocks in Mastectomy Reconstruction Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    60
  • sponsor
    Columbia University
Updated on 26 January 2021
cancer
breast cancer
mastectomy

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.

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.

Details
Condition Breast Cancer Female
Treatment Placebo drug, Placebo Device, Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device, ropivacaine hydrochloride
Clinical Study IdentifierNCT03360214
SponsorColumbia University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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