Experience with a Nonopioid Protocol in Ambulatory Breast Surgery: Opioids are Rarely Necessary and Use is Surgeon-Dependent



 

Kara A Rothenberg, MD1; Michelle R Huyser, MD1; Joanne K Edquilang, MD1; Elizabeth L Cureton, MD2;
Rita O Kwan, MD, MPH2; Peter D Peng, MD2; Jonathan D Svahn, MD2; Veronica Shim, MD2

Perm J 2019;23:18-127 [Full Citation]

https://doi.org/10.7812/TPP/18-127
E-pub: 03/18/2019

ABSTRACT

Context: Surgeons write 1.8% of all prescriptions and 9.8% of all opioid prescriptions. Even small doses prescribed for short-term use can lead to abuse; thus, surgeons are uniquely able to combat the opioid epidemic by changing prescribing practices. As part of a departmentwide quality improvement project, we initiated a nonopioid protocol for all patients undergoing ambulatory breast surgery.
Objective: To determine the feasibility of a nonopioid protocol for patients undergoing ambulatory breast surgery and to determine if patient-related factors contribute to surgeon adherence to a nonopioid protocol in ambulatory breast surgery.
Design: Retrospective chart review of a prospectively collected database, with c2 analysis and a multiple logistic regression model with the surgeon as the random effect.
Main Outcome Measure: Protocol adherence.
Results: A total of 180 patients, with a median age of 63 years (range = 18-95 years), were included. Of these, 127 (70.6%) did not receive opioids; in this group there were 2 hematomas (1.6%), and 3 patients required an opioid prescription (2.4%). Fifty-three (29.4%) were prescribed opioids against protocol; in this group, there was 1 hematoma (1.9%). The operating surgeon was the only variable independently correlated with protocol adherence (p < 0.0001). Age, race/ethnicity, surgery type, and history of long-term opioid use were not.
Conclusion: Ambulatory breast surgery patients tolerated a nonopioid pain regimen well. Surgeons’ decisions, rather than patient characteristics, primarily drove the choice of pain management in our study. We believe our protocol can be improved with stricter implementation and education, which must be balanced with practitioner independence.

INTRODUCTION

Opioid use was associated with approximately 33,000 deaths in the US in 2015.1 Although opioids are sometimes necessary in the acute postoperative period, there is still a substantial risk of dependency,2 opioid-induced hyperalgesia,3 and opioid-related adverse events.4 Many opioid-related adverse events, such as nausea, vomiting, fatigue, confusion, or constipation, seem benign, but they have been associated with increased length of stay, cost, readmission rates, and inpatient mortality.3

Surgeons write only 1.8% of all prescriptions, yet they write 9.8% of all opioid prescriptions.5 Many of these prescriptions are written for opioid-naïve patients in the immediate postoperative period, which may not always be necessary.4 Thus, surgeons have a unique opportunity to limit opioid prescriptions in the appropriate settings. Ambulatory surgery, particularly breast surgery, is one of the settings where opioids can be decreased or possibly eliminated.4,6-8

To decrease unnecessary opioid prescriptions in our practice, we decided to institute a nonopioid protocol for all ambulatory breast surgeries performed in our practice. The goals of the study were to determine if patients in our practice could have pain adequately managed after ambulatory breast surgery without opioids and to describe our experience with a protocolized discharge plan. Because the protocol was not strictly enforced, we also analyzed those who did not receive the protocol to determine whether patient characteristics were associated with protocol adherence by the surgeon.

METHODS

The nonopioid protocol began in June 2016, and we reviewed the charts of all ambulatory breast surgery patients from July 2016 to July 2017. Ambulatory breast surgery in our practice was defined as any patient having a lumpectomy with or without sentinel lymph node biopsy (SLN) and/or intraoperative radiation therapy (IORT). Seven surgeons were in our practice, and the data of all 7 surgeons were included, whether or not they chose to follow the nonopioid protocol. No patients, including those with a diagnosis of chronic pain or long-term opioid prescriptions, were excluded. Baseline characteristics of the patients are listed in Table 1.

The protocol suggested counseling regarding pain management expectations as well as prescriptions of acetaminophen and ibuprofen to manage pain; however, there were no strict restrictions or mandates preventing opioid prescriptions. Follow-up included a secure phone call or secure message from our breast care coordinator within 1 to 3 days of surgery and a clinic visit 1 to 2 weeks postoperatively. As with all practices in our integrated health system, all patients received discharge instructions and the phone number for our 24-hour regional call center. If patients called the regional call center or presented to the Emergency Department with pain not responsive to acetaminophen or ibuprofen, they were given an opioid prescription. Also, during postoperative Day 1 follow-up, patients were asked about their pain, and if they requested opioid medications or described moderate to severe pain, a prescription was written.

Of the patients who received the protocol, failure was measured by opioids prescribed within 14 days of discharge from the postanesthesia care unit, which was captured by review of secure patient messages, call center logs, follow-up appointment notes, and prescriptions. For patients with long-term opioid prescriptions, failure was measured in the same way; however, refills of the normal prescription by the primary prescriber were not counted. Because the protocol was not strictly enforced, a group of patients were still prescribed opioids, and these patients were further analyzed to improve protocol adherence. Our chart review was performed retrospectively for the purposes of quality improvement; thus, approval from the institutional review board was not required.

We assessed the association of patient- and surgeon-level characteristics with the probability of an opioid prescription using R software (R Foundation), c2 analysis, and a logistic regression model with a random intercept for surgeons.

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RESULTS

We reviewed the charts of 180 consecutive patients. The median age of all 180 patients was 63 years (range = age 18-95 years). Procedures were lumpectomy only (29.4%), lumpectomy with SLN (47.8%), or lumpectomy with SLN and IORT (22.8%). Of the 180 patients, 53 (29.4%) were prescribed postoperative opioids during the study period despite the nonopioid protocol. There were 3 complications, all hematomas requiring that patients be taken back to the operating room. Two of these patients received the nonopioid protocol and 1 did not. Of the 127 patients (70.6%) who received the nonopioid protocol, 3 (2.4%) were later prescribed opioids because of pain not controlled by the protocol. Results are summarized in Table 2.

Chi-squared analysis showed that the operating surgeon was the only variable independently correlated with protocol adherence (p < 0.0001). In our logistic regression with the surgeon as a random effect, neither age, race/ethnicity, surgery type (lumpectomy only, lumpectomy with SLN, or lumpectomy with SLN and IORT), nor history of long-term opioid use was associated with protocol adherence. Interestingly, when surgeons who were more adherent to the protocol strayed from it, further chart review showed that the opioids were often prescribed by a resident physician not familiar with the protocol.

DISCUSSION

In this study, we evaluated our implementation of a nonopioid policy in ambulatory breast surgery, and the results suggest that opioids can be safely eliminated from the postoperative analgesic regimen of nearly all patients. Perhaps more interestingly, we found that in our practice, postoperative analgesic regimens appear to be driven by the surgeon rather than patient characteristics such as age, race/ethnicity, surgery type, or even a history of chronic pain.

It has already been shown that opioids are overprescribed, but determining an appropriate number to prescribe has been more difficult. Results of a retrospective study of patients who underwent general surgery showed that 70% of prescribed opioids were never taken.4 These authors’ subgroup analysis showed that after partial mastectomy and partial mastectomy with SLN, 85% and 74% of prescribed opioids, respectively, were not taken.4 Others have shown that opioids may be eliminated completely after ambulatory surgery.7,8 Findings from a double-blind randomized trial in 2012 showed no difference in pain scores after ambulatory breast surgery between a group of patients receiving acetaminophen with codeine (Tylenol no. 3) or a combination of nonsteroidal anti-inflammatory drugs with acetaminophen (Tylenol).6

Despite evidence that opioids can be reduced or eliminated, 99% of surgical patients still receive postoperative opioid prescriptions upon discharge.9 Physician adherence rates to clinical practice guidelines in general can range anywhere from 20% to 99%.10-12 The discordance between evidence and prescriber practice has been bridged with success in primary care and acute settings, where education and protocols have decreased the number of opioid prescriptions.13-15 However, even in the setting of a protocol, our study had only 70.6% adherence. Discussions with our surgeons elicited that those who went against protocol were “assuming it wouldn’t work” and that “some patients seemed like they would need them.” Often, the decision to prescribe opioids and the number to prescribe appear to be based on routine, rather than taking the patient and surgical procedure into consideration.16 Our results are valuable because we have a better understanding about the drivers for these prescriptions, and our results imply that the burden for reducing opioid prescriptions falls on the prescriber. Although protocols may be a way to improve guideline compliance and translate the evidence into practice, we recognize that practitioner independence, patient autonomy, and other patient-related factors should play a role in prescribing practices as well.

In our study, only 3 (2.4%) of the patients in the nonopioid protocol required opioids, which suggests that not prescribing these medications at all may be effective for most patients who undergo ambulatory breast surgery in our practice. It should be noted that in our integrated health system, patients have access to a 24-hour regional call center that is directly linked to a 24-hour pharmacy to obtain an opioid prescription rather easily and quickly. We would therefore caution other practitioners to confirm that reliable backup methods exist before initiating a nonopioid protocol. If backup methods are less reliable, it may be more reasonable to protocolize the number of opioids prescribed, which can be done using guidelines from the Michigan Surgical Quality Collaborative and the Michigan Opioid Prescribing Engagement Network.17

One of our particularly interesting findings was that when our more adherent surgeons strayed from the protocol, further chart review showed that the opioids were prescribed by a resident not familiar with the protocol. Before the protocol started, it was discussed in the Breast Surgery Department’s monthly conference call and in an email to all attending surgeons in the department. Because residents participate in nearly all our cases, this study reminded us that we also need to discuss protocol changes with all stakeholders, including residents. Since our study analysis, we are working to publicize the policy during resident teaching sessions, and we are trying to verbally reinforce the protocol on operative days. Further steps might include creating a discharge order set specifically for ambulatory breast surgery. Another potential step might be to create a pop-up reminder in the electronic health record when opioids are prescribed after ambulatory breast surgery, which requires the prescriber to enter an explanation why opioids are being prescribed.

Our study is limited by a small sample size. Because of the size of our cohort, our study was not powered for statistical significance with our complication rates between the 2 groups (opioids vs no opioids). However, the complication rates in both groups were very low (1.6% in the nonopioid group and 1.9% in the opioid group), and there were no readmissions in either group. Our sample size also limited our analysis of patients with long-term opioid use. Although we found it did not influence prescribing practices, we were unable to determine whether chronic pain or long-term opioid use influenced protocol failure. Other studies have not included patients with chronic pain,6 and we believe it would be important to include these patients in future larger, prospective studies.

CONCLUSION

Our study results show that surgeons hold the most influence over the postoperative pain regimen and can likely help reduce the opioid epidemic by eliminating or reducing opioid prescriptions after ambulatory surgery. Protocols may be a way to do this safely without increased harm to the patient. We anticipate future studies with analysis of our protocol effectiveness, particularly as we expand and refine the protocol with respect to evidence and practitioner autonomy.

Disclosure Statement

The author(s) have no conflicts of interest to disclose.

Acknowledgments

Kathleen Louden, ELS, of Louden Health Communications provided editorial assistance.

How to Cite this Article

Rothenberg KA, Huyser MR, Edquilang JK, et al. Experience with a nonopioid protocol in ambulatory breast surgery: Opioids are rarely necessary and use is surgeon-dependent. Perm J 2019;23:18-127. DOI: https://doi.org/10.7812/TPP/18-127

Author Affiliations

1 Department of Surgery, University of California San Francisco-East Bay, Oakland, CA

2 Department of Surgery, Kaiser Permanente, Oakland, CA

Corresponding Author

Veronica Shim, MD (veronica.shim@kp.org)

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Keywords: breast pain, pain management, patient safety, surgery

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