Seeking to better understand the use and potential abuse of opioids following cesarean delivery, The Ohio State University Wexner Medical Center is playing an active role in The Prescription After Cesarean Trial, or PACT, to help the National Institutes of Health (NIH) find science-based solutions to solve the national opioid crisis.
As part of the NIH Helping to End Addiction Long-termSM (HEAL) Initiative, Ohio State is one of two academic centers in Ohio and only 12 nationwide that are members of the National Institute of Child Health and Human Development – Maternal Fetal Medicine Units (MFMU) Network, which is the group conducting PACT.
According to the study overview, “Cesarean delivery, or C-section, is the most common major surgery done in the United States, and opioids are almost universally prescribed for pain management after a C-section. Research indicates that 1 in 300 U.S. women who are prescribed opioids after a C-section go on to chronically misuse opioids. The number of opioid tablets prescribed can also vary between providers and hospitals, and researchers estimate that most women receive at least 10 more tablets than necessary.”
The study is led locally by Kara Rood, MD, an Ohio State Maternal Fetal Medicine specialist and the medical director of the Substance Abuse, Treatment, Education and Prevention Program (STEPP) clinic at Ohio State. Maged Costantine, MD, the principal investigator for Ohio State’s MFMU center, explains, “We are interested in understanding whether we can use the correlation between how many pain pills a woman takes in the hospital during the 24 hours before discharge and how many she takes once she is home.
“We know that approximately 40-50% of current opioid prescriptions are not finished, which leaves tremendous potential for abuse by the patient and other members of her household or others in the community. At the same time, the women who do finish the prescription are at higher risk of long-term abuse themselves, so we want to limit that.”
For the study, women who had a cesarean delivery will be placed in one of two randomly generated groups at discharge. The first group will be provided a fixed number of opioid pain pills; the second will receive a number based on an individualized assessment of their pre-discharge needed pain pills. Using a shared decision model, this second group of women will also have the opportunity to adjust the number of pills they prefer, from zero to 20 tablets, and receive instructions on tapering the dosage.
The current protocol is for both groups to have frequent telehealth and in-person visits postpartum. Evaluation will include perceived pain levels, as well as the total number of opioid pills actually taken and any side effects.
“Our goal is to improve our ability to target appropriate prescription dosage and quantities to each patient and include each woman in the decision-making process,” Dr. Costantine says. “A woman who did not rely on much pain medication in the hospital should not be sent home with more opioids than necessary. At the same time, we don’t want to provide an insufficient prescription to a patient who is truly struggling with pain or overlook the potential for long-term opioid abuse.”