Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
More than 16 million people have surgery in the United States each year. After surgery, patients may have acute, or short-term, pain. Medicines, such as opioids and nonsteroidal anti-inflammatory drugs, or NSAIDs, can help patients manage their pain. But some pain medicines have risks. For example, patients may become addicted to opioids.
In this study, the research team is comparing opioids and NSAIDs. The team wants to see how well each works to help patients manage their pain after surgery. The team is also comparing the harms of each medicine.
Who can this research help?
Results may help patients, their families, and doctors when considering ways to manage pain after surgery.
What is the research team doing?
The research team is enrolling 900 patients from four health systems. All patients are scheduled to have gallbladder, hernia, or breast lump removal surgery. The team is assigning patients by chance to receive opioids or NSAIDs after their surgery. All patients are also receiving acetaminophen to help manage their pain.
Then, the research team is surveying patients about their experiences after surgery. Patients rate their level of pain in the first week after surgery and again one, three, and six months later. Surveys ask patients about:
- Side effects from the medicine
- Quality of sleep
- Quality of recovery
- Trips to the emergency room for pain
- How much pain affects their life
- Use of drugs or alcohol
The research team is also looking at whether patients use NSAIDs or opioids in ways other than prescribed. Examples include taking more pills at one time or taking them more often than prescribed.
Patients who have had pain after surgery, healthcare providers, health insurers, and community groups are helping to plan and conduct this study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 900 adults scheduled for gallbladder removal, hernia repair, or breast lump removal surgery |
| Interventions/ Comparators |
|
| Outcomes |
Primary: intensity of pain, safety (adverse medicine-related symptoms) Secondary: patient-reported sleep disturbance, perception of improvement after treatment, pain interference, anxiety, depression, and quality of life; clinically important adverse events; substance use; opioid misuse; chronic pain; healthcare utilization related to pain; quality of recovery |
| Timeframe | 1-week follow-up post-surgery for primary outcome |