Clinical trial NCT03360214: PEMF and PEC Blocks in Mastectomy Reconstruction Patients
Official title: A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer Female
Keywords: Mastectomy
Tissue expander
PEMF
PIB
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention
timeFrame: 1 hour post-intervention
measure: Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention
timeFrame: 3 weeks post-intervention
Secondary outcomes:
measure: Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention
timeFrame: 1 hour post-intervention
measure: Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention
timeFrame: 3 weeks post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Christine Rohde, MD
role: PRINCIPAL_INVESTIGATOR
References: