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PEMF and PEC Blocks in Mastectomy Reconstruction Patients

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Columbia University

Status and phase

Completed
Phase 4

Conditions

Breast Cancer Female

Treatments

Other: Placebo Device
Drug: Ropivacaine Hydrochloride
Device: Pulsed Electromagnetic Field (PEMF) Device
Other: Placebo Drug
Drug: Bupivacaine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03360214
AAAQ4708

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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