All patients will receive a baseline infusion of Ringer's lactate at 3ml/kg/hr to satisfy maintenance fluid requirements. The intervention will commence at anesthesia induction and continue for up to 4 hours postoperatively. In addition to maintenance fluids, patients will receive 250ml fluid challenges with crystalloid as required until they are no longer fluid responsive. The absence of fluid responsiveness will be defined as the absence of a sustained rise in stroke volume of at least 10% for 20 minutes or more, at which point, the patient will be considered fluid optimized. At this point, a low-dose dobutamine infusion at a fixed rate (2.5 μg/kg/min) will be commenced and maintained until 4h postoperatively. The infusion rate will be halved and/or discontinued if the patient develops a tachycardia (heart rate ≥ 100bpm) for more than 30 minutes despite adequate anesthesia/analgesia and fluid status.

Patients in the control group will also receive a baseline infusion of Ringer's lactate at 3ml/kg/hr to satisfy maintenance fluid requirements, which will be commenced upon admission to the operating room. The anesthetic management will otherwise be according to standard practice. No specific cardiac output monitoring device will be used to guide fluid therapy. Likewise, perioperative dobutamine will not be used unless clinically indicated to improve cardiac function.

Perioperative Tissue Oxygenation

No it is not based upon gender identity. However this study is based upon sex because it examines an intervention used during DIEP flap breast reconstruction surgery which is most often performed on women.

intraoperative fluid administration will be guided by cardiac output monitoring

Dobutamine

Kingston General Hospital

Hotel Dieu Hospital

Improving Tissue Oxygenation in Breast Reconstruction Surgery

Can Dobutamine and Goal-Directed Fluid Therapy Improve Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery? Randomized Controlled Trial

Tissue oxygenation of the breast tissue flap (measured via near-infrared spectroscopy (NIRS)), 20 minutes following vascular re-anastomosis of the DIEP flap within the perfusion zone that is furthest away from the perforator vessels.

Tissue oxygenation of the breast tissue flap (measured via infrared spectroscopy)

partial or total flap loss, necrosis, need for reoperation etc.

incidence of nausea & vomiting, infection, hematoma

Cumulative amount (of each) of colloids, crystalloids, blood products, vasopressors

length of time from end of surgery to hospital discharge or readiness to discharge (hours)

overall patient reported satisfaction with surgical procedure (scale of 0-10)

Dr. Glenio Mizubuti (MD, MSc)

Dr. Glenio Mizubuti (MD, MSc), Anesthesiologist

Queen's University

Patients will receive Ivivi Torino II PEMF Device

Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields

Sham PEMF Device

Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours.

PEMF Device

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index (BMI)

We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.

Pain Score Measured by Visual Analog Scale

We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis

Patients will receive inactive device
Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields

Patients will receive Ivivi Torino II PEMF Device
Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours. Supplied by Ivivi Health Sciences, LLC.

Number of Narcotic Pain Medications

Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.

Levels of Cytokines

Overall Study

Dr. Christine Rohde

Other Reconstructive Surgery

Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields

The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours. Supplied by Ivivi Health Sciences, LLC.

fat necrosis/nausea

Improving Tissue Oxygenation in Breast Reconstruction Surgery

Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery

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