Opioid-Free Pain Control for Orthopaedic Surgery Recovery

(CORE Trial)

This trial aims to determine if individuals recovering from certain orthopedic surgeries can manage pain without opioids, which are strong painkillers. Researchers will compare two groups: one using opioids and another using alternative pain management methods such as Gabapentin (a nerve pain medication) and Tylenol. The trial targets individuals scheduled for surgeries like hip or shoulder replacements or specific foot surgeries. Those who regularly use opioids or have certain health issues, such as liver disease, are not eligible. The trial will evaluate the effectiveness of each pain management approach in terms of pain relief, comfort, and satisfaction. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance pain management options for future patients.

The trial information does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants (blood thinners) other than aspirin, you cannot participate in the randomized part of the study, but you can join the observational control group.

Research shows that managing pain without opioids can be a safe option after surgery. Studies have found that medications like Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac work well. Patients did not experience more pain than those who used opioids.

One study found these opioid-free methods to be just as effective and safe as opioids for several common surgeries, without leading to more problems or severe pain.

All medications in the opioid-free group have FDA approval, indicating they have been checked for safety in other uses.

Researchers are excited about opioid-free treatments for pain control after orthopedic surgery because they eliminate the risk of addiction associated with traditional opioid medications like Hydromorphone, Hydrocodone, Tramadol, or Oxycodone. Unlike these standard opioid-based options, the opioid-free approach uses alternatives such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac, which are all FDA-approved and not opioids. This method aims to provide effective pain relief while minimizing side effects like drowsiness and nausea, offering a safer recovery process for patients.

This trial will compare opioid-based pain management with opioid-free methods for orthopedic surgery recovery. Research has shown that managing pain without opioids can be as effective as using them post-surgery. Several studies have found no major difference in pain relief between opioid and non-opioid methods in the first 24 hours after surgery. Some research even suggests that avoiding opioids might lead to better recovery and reduced future need for them. Participants in the opioid-free arm of this trial will receive medications like Gabapentin, Tylenol, and Bupivacaine, which effectively manage pain without opioid side effects. Overall, current evidence supports that managing pain without opioids can safely and effectively control post-surgical pain.¹²³⁴⁶