Study Evaluates Effect of Restrictive Opioid Protocol After Gynecologic Surgery

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THE NUMBER of opioids prescribed after surgery for gynecologic cancer decreased significantly after implementation of an ultra-restrictive opioid prescription protocol, with no apparent negative effect on patient satisfaction or pain, according to research presented by Jaron Mark, MD, and colleagues, at the 2018 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in New Orleans.1 

The United States is in the midst of an opioid crisis. More than 100 Americans die daily of an opioid overdose, and although the United States accounts for just 4.4% of the world’s population, it consumes about 30% of total opioids. “There are many contributing factors, one of which is prescribers, such as us,” said Dr. Mark, of Roswell Park Comprehensive Cancer Center in Buffalo, New York. “Prescribing opioids has been routine practice for us, even for minor acute pain after minor surgeries and procedures. We all know it takes 30 seconds to give patients an opioid prescription, but it takes 30 minutes to tell them ‘no.’” 

Over a 6-month period, the researchers observed a 73% decrease in opioid prescriptions for open cases and up to a 97% decrease for patients who underwent minimally invasive procedures. Implementation of the program also decreased the opioids dispensed to patients with a history of chronic opioid use by 83%, and opioid refills remained low. 

Current Practice for Postoperative Pain Management 

PRIOR TO the implementation of the protocol, Dr. Mark and his colleagues sent out a survey to practicing gynecologic oncologists in the United States. They found that 78% of respondents were giving anywhere between 11 and 40 opioid tablets after minimally invasive surgery, and 78% were prescribing 21 to 40+ opioid tablets after a laparotomy. 

In their own practice, they observed that many of the patients who were prescribed opioids after minimally invasive surgery did not actually take them. “We also know that in developed countries in Europe and Asia, where patients have good access to care, many of them are not prescribed routine opioids after a surgical procedure,” Dr. Mark noted. 

“[For minimally invasive and ambulatory patients], we went from prescribing an average of 28.1 tablets in our control to less than 1 tablet in our intervention arm. That’s a 97% reduction.”
— Jaron Mark, MD

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With these points in mind, he and his team hypothesized that surgeons overprescribe opioid pain medication to patients undergoing both major and minor ambulatory surgeries, which increases the risk for chronic opioid use, abuse, and diversion. They also suggested that postoperative acute pain could be effectively managed by nonopioid pain medication while maintaining appropriate pain relief after hospital discharge. 

Significant Decrease in Dispense of Opioids 

THE STUDY consisted of 337 gynecologic oncology patients evaluated from June 2017 to January 2018. The control group consisted of the prior year’s 626 patients, and there were no significant differences in patient characteristics between the two groups. 

As part of this ultra-restrictive opioid protocol, patients with no history of chronic pain who underwent minimally invasive or ambulatory surgery, including all robotic, laparoscopic, and vulvar cases, were prescribed 600 mg of ibuprofen and 500 mg of acetaminophen daily. If a patient required ≥ 5 pills/doses of opioids upon admittance to the hospital, they were prescribed hydrocodone/acetaminophen (5 mg/325 mg) or oxycodone/acetaminophen (5 mg/325 mg), not to exceed 12 pills total over the course of 3 days. 

Like the minimally invasive and ambulatory patients, patients undergoing open surgery received nonopioid pain medication and a 3-day opioid prescription at discharge. However, if while hospitalized, a patient showed an increased need for opioid pain medication and used an opioid in the previous 24 hours, then a 3-day supply consisting of 24 pills (2 pills every 6 hours as needed) was prescribed. Patients also received preoperative education about postoperative pain management. 

Among all patients, there was an 89% reduction in opioids dispensed on hospital discharge: The average number of tablets prescribed dropped from 31.7 to 3.5. According to Dr. Mark, data from the minimally invasive and ambulatory patients were most striking. “We went from prescribing an average of 28.1 tablets in our control to less than 1 tablet in our intervention arm,” he said. “That’s a 97% reduction, which was significant.” 

“We were quite surprised by how few inquiries and requests for medication we got from our patients.”
— Jaron Mark, MD

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The number of patients going home without an opioid prescription after minimally invasive procedures increased from 19.6% to 92.6% (P < .001). Patients who underwent laparotomy saw a 73% decrease in opioids dispensed (43.6 vs 11.6 pills, P < .001). Dr. Mark and colleagues also looked at opioid-naive vs opioid-dependent patients. Both groups saw significant reductions in opioid use: 90% and 83% respectively (P < .001). 

The proportion of patients requesting refills within 30 days after surgery did not change significantly, and mean postoperative pain scores were identical before and after implementation of the protocol (P = .34). 

“We were quite surprised by how few inquiries and requests for medication we got from our patients,” said Dr. Mark. “We expected we would be able to reduce the use of opioids without detrimental consequences, but the extent to which our hypothesis was supported by these results was really striking.” He added that setting preoperative expectations with patients about pain management increases their compliance at discharge. 

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According to the invited study discussant, Sean C. Dowdy, MD, of the Mayo Clinic in Rochester, Minnesota, this study showed that most patients undergoing open or minimally invasive gynecologic surgery require little or no opioid medication. But the availability and use of nonopioid alternatives as well as preoperative education of patients are critical elements in a strategy to reduce opioid use. 

DISCLOSURE: Drs. Mark and Dowdy reported no conflicts of interest. 


1. Mark JE, Phoenix D, Gutierrez CA, et al: Tackling the opioid crisis: Implementation of an ultra-restrictive opioid prescription protocol in patients undergoing major gynecologic surgery radically decreased dispensed opioid without reducing pain control. 2018 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. Abstract 7. Presented March 24, 2018.




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