Pain Protocol Facilitates Outpatient Mastectomy

In In The News by Barbara Jacoby

By: Christina Frangou

From: clinicaloncology.com

Mastectomy patients treated with a multimodal pain control regimen that included liposomal bupivacaine experienced low levels of postoperative pain, allowing them to be discharged home the same day and with a reduced need for opioids during recovery, according to a presentation at the 2018 Clinical Congress of the American College of Surgeons.

“This is not only encouraging as something preventative in a fight back against the opioid epidemic itself, but it is encouraging that we’re making sure that we’re doing the right thing by our patients,” said Cameron T. Ward Coker, MD, one of the study authors and a fourth-year surgical resident at Louisiana State University Health Sciences Center New Orleans.

Study author and principal investigator Adam I. Riker, MD, a surgical oncologist at the University Medical Center New Orleans, developed a protocol for pain control during mastectomy using liposomal bupivacaine (Exparel, Pacira Pharmaceuticals).

Liposomal bupivacaine is a newer extended formulation of bupivacaine that was approved by the FDA in October 2011 for single-dose infiltration into the surgical site. It functions as a nerve block when injected adjacent to the intercostal rib spaces near the armpit and results in prolonged anesthesia for up to three days. Regular bupivacaine, in contrast, typically works over seven hours or less.

Patients received a standardized pain regimen that included 1 g of IV acetaminophen intraoperatively, combined with a nerve block with liposomal bupivacaine injected into the intercostal space at four to five different levels and 30 mg of IV ketorolac. All women in this series were discharged home later that day with acetaminophen with codeine.

Investigators reviewed 72 consecutive patients who underwent mastectomies—11 bilateral (15.3%) and 61 unilateral (84.7%)—between November 2015 and July 2017. They had an average age of 57 years, with an average body mass index of 30 mg/kg2.

Three patients later presented to the emergency department because of pain. Of these, none required hospital admission. The authors did not specify whether these patients underwent bilateral or unilateral mastectomies, nor did they specify how long after surgery these patients presented with pain.

Dr. Riker said he began using liposomal bupivacaine eight years ago in other patients. He extended its use to mastectomy patients several years ago in an effort to reduce their postoperative oral narcotic needs and help them avoid an overnight stay in the hospital.

“If the nerve block is performed properly, the vast majority of patients wake up in the recovery room with little or often no pain whatsoever,” Dr. Riker said. “After the operation, our patients go home with a prescription for a few days of acetaminophen-codeine rather than acetaminophen-oxycodone, which is a much stronger opioid that has a very high potential for opioid abuse.”

In 2016, surgeons from Mayo Clinic in Rochester, Minn., reported a retrospective review of 97 patients who underwent mastectomy with immediate tissue expander reconstruction between May 2012 and October 2014. Of these, 44 patients received a preoperative ultrasound-guided paravertebral block and 53 had intraoperative liposomal bupivacaine infiltration (Ann Surg Oncol 2016;23[2]:465-470).

Liposomal bupivacaine was associated with less opioid use in the PACU (P<0.001), fewer patients requiring antiemetics (P=0.03), and lower pain scores on the day of surgery (P=0.008). It also was associated with longer time to first opioid use (P=0.04). There was no difference in the proportion of patients discharged within 36 hours of surgery between the groups.

Dr. Riker said he hopes the findings will encourage surgeons to review their approaches to pain control for mastectomy patients, saying it could lead to higher patient satisfaction, shorter hospital stays and reduced costs.

“Some surgeons are locked into the dogma that you have to keep a mastectomy patient in the hospital overnight, but I really think that utilization of this multimodal approach allows for a safe and effective alternative,” Dr. Riker said.

The idea of outpatient mastectomy is not new. It was first reported in the early 1990s by William Dooley, MD, and his colleagues at Johns Hopkins, and it subsequently sparked a heated political debate. More than a dozen states debated legislation that could ban or restrict outpatient mastectomies, on the premise that limited insurance coverage for longer hospital stays could push women out of hospitals before it was safe for them to go home. In his 1997 State of the Union address, former President Bill Clinton criticized same-day mastectomies as “dangerous and demeaning.”

Since then, however, much has changed. Studies show ambulatory surgery for mastectomy is safe and effective with equivalent complication rates and high psychological satisfaction, according to a 2016 summary of the evidence (Am J Surg 2016;211[4]:802-809).

Between 1993 and 2000 alone, the proportion of women with breast cancer receiving same-day surgery increased from 3.2% to 19.4% for mastectomy patients. In 2016, the Agency for Healthcare Research and Quality reported that the rate of bilateral outpatient mastectomies increased more than fivefold between 2005 and 2013. By 2013, nearly half of all mastectomies were performed as outpatient procedures.

Dr. Dooley, now a professor of surgery at the University of Oklahoma in Oklahoma City, said a tremendous cultural shift has occurred in the past two decades since the first outpatient mastectomies were reported. In his own practice, the change happened in four years: Between 1992 and 1996, the percentage of patients who chose to go home the same day as surgery rose from 3.2% to 96%.

“There are a variety of local anesthetic techniques you can use, and it doesn’t really matter which way it is done; the result is it helps to limit the amount of narcotics. If you can limit the amount of nausea and narcotics, you have patients recover quicker and proceed through all their adjuvant therapies with fewer problems.”

He said efforts to engage and educate patients about treatment and outcomes—along with the Breast-Q (http://qportfolio.org/ breastq/ ), a patient-reported outcome measure designed for patients with breast cancer—have led to improvements in breast cancer care. “It’s really changing the climate around the whole treatment process.”

But some surgeons remain concerned about hurrying patients through the recovery process in the hospital, particularly for older women and/or patients who undergo bilateral mastectomies.

Elisa Port, MD, the chief of breast surgery and director of the Dubin Breast Center at Mount Sinai Hospital, in New York City, sends most patients home within 23 hours of surgery, but prefers to keep patients overnight after bilateral mastectomies.

“There are huge advantages to getting people out of the hospital early, but the same day, after bilateral, I think for many is still a very tall order,” said Dr. Port, who moderated the session where Dr. Riker’s team presented their study.

Dr. Port worries about implications for older patients. The median age of diagnosis for breast cancer in the United States is 62 years, and breast cancer rates are highest among women over the age of 70. Older patients often need assistance with mobility after a bilateral mastectomy, she said. Long-acting local anesthetics wear off 24 hours after surgery or even more. This means patients might already be home when the worst of their pain strikes. A return to the hospital for pain isn’t ideal, she said.

“I think outpatient mastectomy is acceptable to do in well-selected patients who are otherwise fairly healthy, mobile, and at low risk for complications. Other than that, I think that we should keep a low threshold for admitting patients for overnight in the hospital for a day.”

She noted that bleeding is the most common complication after mastectomy. By keeping patients in the hospital overnight, health care providers can check incisions for bleeding in the morning, she said. Typically, bleeding occurs in the first 24 hours, she said.

Multimodal pain management and safe prescribing practices for opioids were major themes at this year’s Clinical Congress.

In 2017, a total of 70,000 opioid-related deaths occurred in the United States. Studies have shown about 3.1% of those who undergo high-risk surgery will become long-term opioid users (BMJ 2014;348:g1251).

Jonah Stulberg, MD, a general surgeon at Northwestern University Feinberg School of Medicine, in Chicago, said changes in pain management around surgical procedures are necessary to curb opioid-related morbidity and mortality.

“Multimodal approaches to pain management are effective in decreasing our reliance on opioid medications around the time of surgery. That is true both in the operating room while the patient is asleep under anesthesia, but also true after the patient leaves the operating room when they’re an inpatient and when they’re discharged.”