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A Randomized Controlled Trial to Reduce Unused Opioids after Cesarean Delivery
Abstract Number: GM-5
Abstract Type: Original Research
OBJECTIVE: Most women have unused opioids after cesarean, a potential source for opioid misuse and diversion. This study examines whether customized opioid prescribing reduces leftover opioids after cesarean.
STUDY DESIGN: Between 6/14/2017 and 8/25/2017, English or Spanish-speaking women >= 18 years undergoing a cesarean were assessed for eligibility. Women with a complicated cesarean or chronic opioid use were excluded. Eligible women were approached postoperative day (POD) 1 and informed consent was obtained. Enrolled women were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5mg oxycodone) vs customized opioid prescription. Customized prescriptions were derived from inpatient opioid use, using a formula established in a prior study. All women were contacted starting POD 14 to assess quantity of opioid tablets used and adequacy of pain control. The TN Controlled Substance Monitoring Database was accessed to confirm dispensed opioids. The primary outcome was leftover opioid tablets. A sample size of 160 women was selected to demonstrate a 30% difference in leftover opioids between both groups with 80% power and an alpha of 0.05.
RESULTS: 323 women were assessed for eligibility, of whom 96 were excluded and 34 declined participation. 190 women were randomized with 18 lost to follow up (9.5%), leaving 172 for the final analysis. There were no differences between the two arms in obstetric characteristics or inpatient opioid use. The predicted tablet number for both arms was 13 (IQR 11-15). Women in the customized arm had 50% less leftover tablets than women in the standard arm (5 [IQR 1-8] vs 10 [IQR 0-22], p<0.001). There were no differences in the proportion of women who used no opioids or all opioids, and no difference in the proportion of dispensed opioids used (60% [IQR 25-93%] overall), however women in the customized arm used 47% less prescribed opioids. There were no statistically significant differences in patient reported pain outcomes although a trend toward higher reported pain was noted among women in the customized group.
CONCLUSION: Opioid prescribing customized to inpatient use reduces leftover opioids. Prescribing less opioids also reduces patients’ total opioid usage. Customized opioid prescribing does not appear to significantly impact patient reported pain outcomes.