By Sophie Neuner Weinstein, MD, MPH, and Lisa Bayer, MD, MPH
Synopsis: A multicenter, randomized controlled trial of 5,521 participants who underwent uncomplicated cesarean deliveries found that an individualized opioid prescription protocol (IOPP) with shared decision-making was noninferior to a fixed prescription regarding the proportion of participants experiencing moderate to severe pain one week post-discharge, while significantly reducing the number of opioid tablets prescribed at discharge (median of 14 tablets vs. 20 tablets, P < 0.001).
Source: Smid MC, Clifton RG, Rood K, et al. Optimizing opioid prescription quantity after cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2024;144(2):195-205.
Cesarean deliveries are the most common surgical procedure performed in the United States.1 Despite this, the number of opioid tablets prescribed post-discharge varies widely, and most patients receive more opioids than they need.2 Drug diversion and accidental ingestion of unused opioids contribute to misuse and overdose, particularly among young children and adolescents.3,4 Additionally, up to 2.2% of opioid-naïve individuals become persistent opioid users following cesarean delivery, further heightening the risk of opioid-related complications.5 Individualized opioid prescription protocols (IOPPs) with shared decision-making is a proposed model to customize the quantity of opioids prescribed and decrease the number of unused opioid tablets after a cesarean delivery.
To explore the efficacy of this model, researchers conducted a multicenter, randomized, controlled noninferiority trial involving 5,521 participants who had uncomplicated cesarean deliveries across 31 centers in the United States from September 2020 through March 2022. The study was designed to test the hypothesis that IOPP with a shared decision-making component is noninferior to a fixed prescription quantity for post-cesarean pain management at one week post-discharge.
The study protocol, which was developed as part of the National Institutes of Health Helping to End Addiction Long-Term (HEAL) Initiative, included postpartum individuals with uncomplicated cesarean deliveries of singleton, twin, or triplet pregnancies, and who had no history of opioid use during pregnancy. Participating individuals were assigned to two groups in a 1:1 ratio: IOPP with shared decision-making and fixed-quantity prescription. Research staff collecting follow-up data were blinded to the treatment group. To estimate risk factors for development of opioid misuse, they collected Opioid Risk Tool (ORT) scores for those who accepted or declined enrollment. Baseline sociodemographic and medical history were collected.
Participants in the IOPP arm received educational counseling, either by a research nurse or in the form of a five-minute video, covering pain expectations, pain management options, background information on the opioid epidemic, and the study intervention. Research nurses calculated the participants’ opioid use over the past 24 hours in morphine milligram equivalents (MMEs) to generate IOPP recommended taper (20% reduction) of MME per day up to a maximum of 20 tablets post-discharge.
Trained research staff members presented the calculated IOPP to the participants and, through shared decision-making, allowed the participant to select their preferred discharge tablet quantity between 0 and 20. The fixed-quantity arm received a standardized discharge prescription of 20 tablets of 5 mg oxycodone without any educational counseling. The primary outcome was moderate to severe pain (score 4 or higher on the Brief Pain Inventory [BPI] severity scale [range 0-10]) at one week post-discharge.
Secondary endpoints included worse BPI pain score at two weeks post-discharge, total MME used by two weeks post-discharge, opioid prescriptions beyond that prescribed at discharge through 90 days postpartum, and number of unused opioid tablets at 90 days postpartum. A noninferiority design was selected, with a noninferiority margin of 5%. To account for 20% loss-to-follow-up rate, 90% power, and a one-sided 0.025 alpha, a sample size of 5,500 was calculated for the primary outcome.
A total of 5,521 individuals were enrolled and randomized (IOPP group, n = 2,748; fixed-quantity group, n = 2,773). ORT scores were similar between those who accepted or declined enrollment in the trial. Among enrolled individuals, demographic, pregnancy, and surgical characteristics were similar between the two groups; however, individuals in the IOPP group were slightly less likely to report using illicit substances in the past year (7.0% vs. 8.7%).
In the IOPP group, participants were recommended a median of nine tablets (range, 0-20) but requested a median of 14 tablets (range, 6-20); 33.7% were recommended 0 tablets, and 25.3% were recommended 20 tablets. After shared decision-making, 46.8% requested the recommended amount, 47.5% asked for more, and 5.7% wanted fewer tablets. Concerns about pain and the inconvenience of needing a new prescription were cited as the most common reasons for requesting more tablets.
There was no significant difference in the percentage of participants reporting worst pain (BPI score 4 or higher) at one week post-discharge; therefore, IOPP with shared decision-making was noninferior to fixed quantity (59.5% vs. 60.1%; risk difference, 0.67%; 95% confidence interval [CI], -2.03% to 3.37%; noninferiority margin, -5.0). At two weeks post-discharge and beyond, the frequency of worst pain remained similar between the two groups.
Participants in the IOPP group used less MME in the two weeks post-discharge compared to the fixed-quantity group (median = 22.5 vs. 37.5). At 90 days postpartum, the proportion of participants who required refills/additional opiate prescriptions was similar between the two groups (7.5% vs. 6.2%; relative risk, 1.22; 96.25% CI, 0.99 to 1.51). At 90 days postpartum, the IOPP group received overall fewer tablets compared with the fixed-quantity group (median, 14; interquartile range, 4 to 20 vs. 20; P < 0.001), and reported a median of five fewer unused tablets (interquartile range, 2 [0 to 8] vs. 7 [0 to 16]; median difference, -5; 97.5% CI, -6.5 to -3.5).
Commentary
As the opioid crisis continues to devastate the nation, many physicians, including OB/GYNs, are becoming more cautious about prescribing opioids at discharge. And with good reason — opioid-related overdose deaths have become a leading cause of mortality among pregnant and postpartum patients.6 With approximately 1.1 million cesarean deliveries annually in the United States, opioid prescriptions at discharge are a sensible focus for targeted intervention.7
This study contributes significantly to harm reduction by demonstrating IOPP combined with shared decision-making can reduce the number of opioid tablets dispensed without compromising pain management after cesarean delivery. The two-tiered approach to prescribing opioids at discharge has significant advantages: It individualizes prescriptions to the patient’s needs and promotes patient autonomy and engagement in their care. The shared decision-making is an important part of this study, and the authors warn against concluding that 14 tablets are an acceptable one-size-fits-all approach.
The study used a multicenter design across 31 U.S. hospitals, recruiting a diverse cohort to enhance generalizability. However, about one-third of individuals assessed for enrollment were ineligible. Notably, high-risk groups for long-term postpartum opioid use, such as those with prior opioid prescriptions or a history of opioid use disorder, were excluded.8 It remains unclear whether IOPP with shared decision-making can reduce opioid dispensation effectively without compromising pain control in these populations. In addition, educational counseling was only performed in the IOPP group. It is unclear how this additional intervention influenced the outcome of the study.
While the downstream effects of IOPP with shared decision-making (i.e., rates of fatal and non-fatal overdose) have yet to be elucidated, the study has significant implications for public health. By prescribing five fewer oxycodone tablets per cesarean delivery, the authors estimate that widespread adoption of the IOPP protocol could keep 5.5 million excess opioid tablets out of U.S. households annually.
So how can we adopt this protocol in the real world? IOPP with shared decision-making needs to be integrated into the postpartum discharge workflow. For example, use of the electronic medical record has been proposed to generate a recommended number of opioid tablets at discharge based on IOPP.9
Importantly, successful implementation requires involvement of all members of the care team. For example, discharge teaching by nursing staff could include an educational component on pain management, as well as informative discussion with the patient to present the MME recommended and determine the number of discharge tablets. Lastly, institutional guidelines must be developed to standardize the IOPP process. Example guidelines are included in Appendix 3 of the study, available online at http://links.lww.com/AOG/D721.
IOPP with shared decision-making is a promising approach to reducing the number of dispensed opioid tablets after cesarean delivery without compromising post-discharge pain control. Future research should prioritize implementation strategies and application of the approach across diverse populations.
Sophie Neuner Weinstein, MD, MPH, is Resident Physician, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR.
Lisa Bayer, MD, MPH, is Associate Professor, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR.
References
1. Sung S, Mikes BA, Mahdy H. Cesarean Section. StatPearls. Updated Oct. 5, 2024. StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK546707/
2. Osmundson SS, Schornack LA, Grasch JL, et al. Postdischarge opioid use after cesarean delivery. Obstet Gynecol. 2017;130(1):36-41.
3. Finkelstein Y, Macdonald EM, Gonzalez A, et al. Overdose risk in young children of women prescribed opioids. Pediatrics. 2017;139(3):e20162887.
4. Gaither JR, Shabanova V, Leventhal JM. US national trends in pediatric deaths from prescription and illicit opioids, 1999-2016. JAMA Netw Open. 2018;1(8):e186558.
5. Landau R, Cavanaugh PF, DiGiorgi M. Persistent opioid use after cesarean delivery in the United States of America: A systematic review. Int J Obstet Anesth. 2023;54:103644.
6. Trost SL, Beauregard J, Chandra G, et al. Pregnancy-related deaths: Data From Maternal Mortality Review Committees in 36 US states, 2017-2019. Centers for Disease Control and Prevention. https://www.cdc.gov/maternal-mortality/media/pdfs/Pregnancy-Related-Deaths-Data-MMRCs-2017-2019-H_1.pdf
7. Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2022. NCHS Data Brief. 2023;(477):1-8.
8. Bateman BT, Franklin JM, Bykov K, et al. Persistent opioid use following cesarean delivery: Patterns and predictors among opioid-naïve women. Am J Obstet Gynecol. 2016;215(3):353.e1-353.e18.
9. Imo CS, Macias DA, McIntire DD, et al. A personalized protocol for prescribing opioids after cesarean delivery: Leveraging the electronic medical record to reduce outpatient opioid prescriptions. Am J Obstet Gynecol. 2024;230(4):446.e1-446.e6.
A multicenter, randomized controlled trial of 5,521 participants who underwent uncomplicated cesarean deliveries found that an individualized opioid prescription protocol (IOPP) with shared decision-making was noninferior to a fixed prescription regarding the proportion of participants experiencing moderate to severe pain one week post-discharge, while significantly reducing the number of opioid tablets prescribed at discharge (median of 14 tablets vs. 20 tablets, P < 0.001).
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