Pain Medication for Postoperative Pain
(CARES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two common pain relief methods for surgeries such as gallbladder removal, hernia repair, or breast lump removal. It aims to determine which is more effective: NSAIDs (a type of pain reliever) plus acetaminophen, or low-dose opioids plus acetaminophen. Researchers believe the NSAID option might be more effective and cause fewer side effects. Individuals who have not used pain medications extensively before surgery and are planning one of these specific surgeries might be suitable for the trial. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you have not used significant pain medications like opioids or NSAIDs recently. If you've used these medications frequently in the past 30 days, you may not be eligible to participate.
What is the safety track record for these treatments?
Research shows that both NSAIDs and opioids have been studied for post-surgery pain relief. NSAIDs, such as ibuprofen and meloxicam, are generally safe for managing short-term pain when used correctly. Studies indicate that NSAIDs have minor side effects similar to other pain medications, without significantly increasing wound problems.
In contrast, opioids often cause more noticeable side effects, including dizziness, drowsiness, nausea, and vomiting. One study found that some opioids, like tramadol, had higher rates of serious side effects compared to others, such as oxycodone and hydrocodone.
In summary, both treatments have been used safely in patients, but NSAIDs typically cause fewer side effects than opioids.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for postoperative pain because they explore different approaches to pain management. The NSAID regimen offers a non-opioid alternative, which could reduce the risk of dependency and side effects associated with opioids. The opioid regimen is being examined to potentially optimize dosing and minimize adverse effects. By comparing these two regimens, researchers hope to find effective pain relief options that improve patient recovery while minimizing risks.
What evidence suggests that this trial's treatments could be effective for postoperative pain?
In this trial, participants will be assigned to different treatment arms to manage postoperative pain. Research has shown that combining NSAIDs (a type of pain reliever) with acetaminophen often manages pain after surgery better than opioids. Participants in the NSAID regimen arm may experience effective pain relief with fewer side effects. Studies have found that NSAIDs can relieve pain more effectively and with fewer side effects. For instance, a review found that NSAIDs worked better than weaker opioids for post-surgery pain. Meanwhile, participants in the opioid regimen arm may find opioids effective, but there is concern about long-term use. Additionally, some opioids may not reduce pain as well as NSAIDs after surgery. Overall, NSAIDs appear to be a safer and more effective choice for many patients.12356
Who Is on the Research Team?
Mark Bicket, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
The CARES trial is for patients having low-risk surgeries like gallbladder removal, hernia repair, or breast lump removal. They must not have used significant pain medication recently and should be free from other surgeries or life-threatening conditions in the next 6 months. Those with specific allergies to NSAIDs, opioids, or acetaminophen can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either NSAIDs plus acetaminophen or low dose opioids plus acetaminophen for pain management post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity and adverse events
Long-term follow-up
Participants are monitored for chronic pain and healthcare utilization related to pain
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
- NSAID
- Opioid
NSAID is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Pain relief
- Inflammation
- Fever reduction
- Postoperative pain management
- Pain relief
- Inflammation
- Fever reduction
- Postoperative pain management
- Arthritis
- Menstrual cramps
- Pain relief
- Inflammation
- Fever reduction
- Postoperative pain management
- Pain relief
- Inflammation
- Fever reduction
- Pain relief
- Inflammation
- Fever reduction
- Pain relief
- Inflammation
- Fever reduction
- Postoperative pain management
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator