Columbia University Irving Medical Center
New York, 10032, United States
NCT Number: NCT03360214
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.
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Female
Interventional
Phase 4
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For active drug, 0.25% marcaine, will be used.
Other names: Marcaine, PIB
For sham drug, 0.9% saline, will be used.
Other names: Saline
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 names: Sofpulse, Torino II
Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.
For active drug, 0.25% naropin, will be used.
Other names: Naropin, PIB
Time frame: 1 hour post-intervention
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.
Time frame: 3 weeks post-intervention
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.
Time frame: 1 hour post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Time frame: 3 weeks post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Columbia University
Other
A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction
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