A team of surgeons is working to identify the most effective strategy to treat acute pain after injury while minimizing the amount of opioids prescribed to trauma patients, building on a previous project that decreased use of the highly addictive class of drugs by 40 percent.

John A. Harvin, MD, MS, associate professor in the Department of Surgery at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), is leading the comparative effectiveness clinical trial at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center, where he is an attending trauma surgeon.

“In 2013, we started prescribing an opioid-minimizing treatment strategy as a first-line pain regimen and prescribing opioids only as needed,” said Harvin, the principal investigator of the study. “Since then, we have changed the culture of acute pain management by setting realistic expectations of pain control, administering large amounts of effective, non-opioid pain medications, and educating providers and patients on safe opioid use. This clinical trial will help us identify the best treatment system for pain and move toward our goal of zero opioids after injury.”

The randomized study, called the “Multi-Modal Analgesic Strategies in Trauma,” assesses two different combinations of various non-opioid pain relievers, like acetaminophen, naproxen, and gabapentin, in high doses to manage patient comfort without relying solely on opioids.

The National Institute on Drug Abuse reports more than 130 people die every day from opioid overdose. Many in the medical community say the problem stems in part from standards issued by The Joint Commission in 2011, which required pain to be assessed as a fifth vital sign and encouraged more aggressive pain treatments, including opioids.

“Since then, many health care providers have relied on opioids as the main method to manage pain,” said Harvin, who is in the Division of Acute Care Surgery at McGovern Medical School at UTHealth. “While prescription drugs from surgery are not the only cause of this epidemic, they contribute greatly. Research shows 75 percent of patients undergoing treatment for heroin addiction were introduced to opioids via prescription drugs, and 6 percent of patients undergoing surgery will go on to long-term opioid use. The best way to decrease someone’s risk for long-term use is to minimize their exposure during hospitalization and at discharge, and there are excellent non-opioid medications available that effectively treat pain. We’re excited to be exploring how to best leverage them to improve care.”

In addition to the risk of long-term opioid abuse, a study recently published in JAMA showed that opioids were not superior to non-opioids for treating chronic back or hip pain.

“Despite opioids having been the go-to drug for pain control, there is actually not high-quality evidence that they provide better pain control,” said Lillian Kao, MD, MS, professor and Jack H. Mayfield, MD Chair in Surgery at McGovern Medical School. Kao is co-principal investigator for the trial. “I’m looking forward to using this project as proof that we can efficiently study issues important to patients and clinicians while obtaining real-time, high-quality data that can change practice.”

The Phase IV trial began in April of 2018 and runs through March of 2019. There are currently more than 1,300 patients enrolled. Harvin plans to publish results by early 2020.