PEMF and PEC Blocks in Mastectomy Reconstruction Patients

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360214
• Other study ID #: AAAQ4708
• Status: Completed
• Phase: Phase 4
• Start date: July 5, 2017
• Est. completion date: March 7, 2022

Study information

• Verified date: March 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Drug:
• Bupivacaine Hydrochloride
For active drug, 0.25% marcaine, will be used.

Other:
• Placebo Drug
For sham drug, 0.9% saline, will be used.

Device:
• Pulsed Electromagnetic Field (PEMF) Device
The pulsed electromagnetic field signal will consist of a 2-m sec burst of 27.12 megahertz (MHz) radiofrequency sinusoidal waves repeating at 2 bursts/second.

Other:
• Placebo Device
Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.

Drug:
• Ropivacaine Hydrochloride
For active drug, 0.25% naropin, will be used.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Visual Analog Scale (VAS)	Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.	Up to 2 years
Secondary	Quality of Recovery Questionnaires (QoR)	Quality of recovery will be measured using QoR. QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. Number "0" indicates none of the time and number "10" indicates all of the time.	Up to 2 years