A randomized controlled double-blind comparison of placebo, pulsed-electromagnetic field device, and pectoral block in mastectomy and reconstruction patients

Contact:

NCT Number:

Protocol:

AAAQ4708

Study Status:

Closed to Accrual, Study Active

Population:

Adult

Phase:

IV

Pain after surgery is common, and it not only affects the post-operative patient experience but is also associated with development of chronic pain and delayed wound healing. Narcotic pain medications are usually prescribed after surgery, but they have many side effects. There are two types of non-narcotic pain control techniques currently in use at Columbia University Irving Medical Center (CUIMC). The first mode uses pulsed electromagnetic fields (PEMF). It is a painless device placed over dressings around the surgical site. The second type of technique uses a numbing medication called bupivacaine or ropivacaine. This medication is injected into the area where surgery will be performed (PIB). Both of these methods have worked well in different types of surgery, but we do not know if one might be more effective than the other or if they are effective in tissue expander breast reconstruction surgeries. The proposed trial is a prospective, randomized, controlled, double- blinded trial to evaluate the efficacy of these two modalities of postoperative pain control in patients undergoing mastectomy and tissue expander reconstruction. 60 patients will be enrolled in one of the following arms: active PEMF + treatment PIB, sham PEMF + treatment PIB, active PEMF + sham PIB, and sham PEMF + sham PIB. Data collection will include general information about you (age, gender, race, and ethnicity) in addition to any medical conditions which you might have, your smoking status, the number of lymph nodes removed during your operation, types of medications given during your operation, the type of mastectomy and reconstruction, and the type and size of expander. After surgery, we will collect information such as pain medication use, nausea/vomiting, and pain level using the visual analog scale (VAS). The primary outcome between the groups will be reduction in pain level as quantified by the VAS scale. Reduction in VAS pain levels will then be compared between all four groups to evaluate the efficacy of PEMF vs. PIB on postoperative pain in patients undergoing mastectomy with tissue expander reconstruction. Other outcomes include a survey of post-operative recovery and use of pain medications.

Are you Eligible? (Inclusion Criteria)

  • All female patients with breast cancer evaluated at CUMC who are undergoing unilateral
  • or bilateral mastectomy with tissue expander reconstruction will be offered enrollment
  • in this prospective study. Patients must be 18 years of age or older..

Specialty Area(s)

Principal Investigator

Profile Headshot
  • Chief of Microvascular Services
  • Chief, Division of Plastic Surgery

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032