PEMF and PEC Blocks in Mastectomy Reconstruction Patients

Phase 4

Completed

• Conditions: Breast Cancer Female
• Interventions: Other: Placebo Drug; Drug: Bupivacaine Hydrochloride; Device: Pulsed Electromagnetic Field (PEMF) Device; Other: Placebo Device; Drug: Ropivacaine Hydrochloride

• Registration Number: NCT03360214
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2017-07-05
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Status Verified: 2022-03
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active PEMF + Treatment PIB	Pulsed Electromagnetic Field (PEMF) Device	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Active PEMF + Sham PIB	Pulsed Electromagnetic Field (PEMF) Device	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Sham PEMF + Sham PIB	Placebo Drug	Participants will receive placebo drug and placebo device.
Sham PEMF + Treatment PIB	Placebo Device	Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Active PEMF + Sham PIB	Placebo Drug	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Sham PEMF + Sham PIB	Placebo Device	Participants will receive placebo drug and placebo device.
Active PEMF + Treatment PIB	Bupivacaine Hydrochloride	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Active PEMF + Treatment PIB	Ropivacaine Hydrochloride	Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Sham PEMF + Treatment PIB	Bupivacaine Hydrochloride	Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Sham PEMF + Treatment PIB	Ropivacaine Hydrochloride	Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

Primary Outcome Measures

Name	Time	Method
Score on Visual Analog Scale (VAS)	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery Questionnaires (QoR)	Up to 2 years	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States