Rectal Methadone for Postoperative Pain

(PROMISE Trial)

This trial tests whether rectally administered Methadone can control pain after spinal surgery. Researchers aim to determine if this method is more effective than a placebo, a look-alike substance with no active medicine. They are also assessing whether this approach reduces the use of other pain medications and improves overall recovery. Individuals undergoing elective spinal surgery with fusion who can provide informed consent may be suitable candidates for this study. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used MAO inhibitors in the last 14 days or if you are taking more than 90 mg of morphine equivalents daily.

Research has shown that methadone is generally safe for managing post-surgical pain. Studies have found that methadone reduces pain and decreases the need for other painkillers. Compared to a placebo and other pain medications like morphine, methadone provides longer-lasting pain relief with fewer doses.

Recent studies support using methadone during surgery, indicating that serious side effects are uncommon. This finding reassures those considering participation in a trial involving methadone. It is well-tolerated for pain management.

Unlike the standard pain management options for postoperative pain, which often involve oral or intravenous opioids like morphine or fentanyl, rectal methadone offers a unique delivery method. This approach allows for a prolonged and steady release of the medication, potentially providing longer-lasting pain relief with a single dose. Researchers are excited about rectal methadone because it can be administered after anesthesia induction, potentially minimizing the need for additional opioids post-surgery and reducing the risk of opioid-related side effects. This could lead to more effective and safer pain management for patients undergoing spinal surgery.

Research has shown that Methadone effectively manages pain after surgery. In this trial, participants in the intervention arm will receive rectal Methadone. Studies have found that this method can provide longer-lasting pain relief and result in less pain compared to a placebo or other pain medications like morphine. Although some studies indicate that Methadone may not always reduce the need for additional painkillers, it generally increases patient satisfaction with pain management. Therefore, using rectal Methadone could be a promising option for pain relief after spinal surgery.¹³⁶⁷⁸