Methadone for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of methadone, an opioid medication, for managing pain after heart surgery. It tests three administration methods: a single dose, a split dose, and a balanced split dose. Individuals scheduled for heart surgery who have not used opioids regularly in the past month may be suitable candidates. The goal is to enhance patient recovery by alleviating post-surgery pain. As an Early Phase 1 trial, this research seeks to understand methadone's effects in people, providing participants an opportunity to contribute to innovative pain management strategies.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as CYP3A4 inducers and inhibitors, and SSRIs (a type of antidepressant). If you are on these medications, you may need to stop them before participating.
Is there any evidence suggesting that methadone is likely to be safe for humans?
Research has shown that a single dose of methadone during surgery is generally well-tolerated. Studies have found it can significantly reduce postoperative pain and decrease the need for additional opioids, without causing severe side effects. For example, one study found that patients who received a single dose experienced less pain and used fewer opioids in the first 24 to 48 hours after surgery.
Similarly, research indicates that administering methadone in split or balanced split doses also appears safe. Although less information is available, some studies suggest these methods can help manage pain after heart surgery without major side effects. Methadone is known for providing long-lasting pain relief, which can be beneficial during surgery.
Since this trial is in an early stage, it primarily aims to confirm these safety findings and determine the optimal dose for pain relief. Methadone is already approved by the FDA for treating pain and addiction, supporting its safety. However, its use specifically for heart surgery is still under investigation in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using methadone for postoperative pain because it offers a potentially longer-lasting pain relief compared to standard opioids like morphine and fentanyl. Methadone's unique mechanism allows it to act on multiple pain pathways, which could mean more effective pain management with fewer doses. Additionally, exploring different dosing approaches—like a single dose at anesthesia induction or split doses after surgery—might optimize its benefits and minimize side effects, offering a tailored approach to managing pain after surgery.
What evidence suggests that methadone might be an effective treatment for postoperative pain?
Research has shown that a single dose of methadone during surgery can reduce pain for up to 72 hours afterward. This approach allows patients to experience less pain and sometimes use fewer other pain medications. In this trial, some participants may receive a single dose of methadone at the induction of anesthesia. Others will receive methadone in split doses post-cardiopulmonary bypass, which studies have found can maintain consistent pain relief and reduce the need for additional opioids. Additionally, some participants will receive balanced split doses of methadone, potentially providing better pain control without requiring higher doses of other painkillers. Overall, methadone’s long-lasting effects make it a promising option for managing pain after heart surgery.25678
Who Is on the Research Team?
Ettore Crimi, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for individuals undergoing cardiac surgery who need pain management. The study aims to find the best methadone dosage for postoperative pain relief. Specific eligibility criteria are not provided, so participants should inquire with the trial coordinators.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methadone during cardiac surgery with cardiopulmonary bypass using different dosing strategies
Postoperative Monitoring
Plasma methadone concentration is measured at various intervals post-surgery to assess pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain intensity and opioid consumption
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor