Duloxetine for Postoperative Pain After Knee Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether duloxetine, a medication, can reduce pain and the need for opioids after knee replacement surgery. The study compares two groups: one receiving duloxetine and another receiving a placebo (a pill with no active medication). It aims to determine if duloxetine manages pain better than current treatments alone. Ideal candidates for this trial are those planning knee replacement surgery due to osteoarthritis and who have not previously used certain mental health medications. As a Phase 4 trial, duloxetine is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial requires that you have not used SSRIs, SNRIs, or serotonergic drugs (except tramadol) in the past 6 months. If you are taking these medications, you would need to stop before participating.
What is the safety track record for duloxetine?
Research has shown that duloxetine is generally safe and can help with pain after surgeries like knee replacements. Many studies have found that participants tolerated duloxetine well, experiencing few serious side effects. Most side effects were mild, such as nausea or fatigue. Since the FDA has already approved duloxetine for other uses, its safety profile is well-established. Therefore, using duloxetine for post-surgery pain is considered safe for most people.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about duloxetine for managing postoperative pain after knee surgery because it offers a unique approach compared to standard treatments like opioids and NSAIDs. Duloxetine is typically used as an antidepressant and for nerve pain, but it has a different mechanism: it works by increasing levels of serotonin and norepinephrine in the brain, which can help modulate pain perception. This could potentially reduce reliance on traditional painkillers, which often come with significant side effects and addiction risks. Additionally, duloxetine is taken orally and can be started before surgery, potentially providing more comprehensive and sustained pain relief.
What evidence suggests that duloxetine might be an effective treatment for postoperative pain after knee surgery?
Studies have shown that duloxetine, which participants in this trial may receive, can effectively reduce pain and lower the need for strong painkillers after knee surgery. Research indicates that patients taking duloxetine feel less pain and can begin rehab exercises sooner. A review of several studies supports that duloxetine helps manage pain and reduces the need for opioids. However, some studies found no major differences between duloxetine and opioids in terms of pain control and function over a year. Overall, duloxetine has proven effective for managing pain after knee replacements.12356
Are You a Good Fit for This Trial?
This trial is for adults under 80 years old who are having a knee replacement due to osteoarthritis and can speak English. They must be willing to follow the study plan and return for check-ups. People with severe health issues, mental disorders, heavy alcohol use, opioid tolerance, or kidney problems cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Treatment
Participants in the experimental arm receive 30 mg of duloxetine daily starting one week prior to surgery
Post-surgery Treatment
Participants continue to receive 30 mg of duloxetine daily for 6 weeks following surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse medication effects and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Duloxetine
- Placebos
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor