A Phase 4 interventional study of Methadone and Standard of Care in Pain Management, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
This study is being done to find out if methadone is more effective in controlling pain in patients presenting for minimally invasive lung resection surgery compared to the standard of care.
Emerging evidence suggests that long-acting opioids may provide more stable analgesia and reduce overall opioid requirements in the perioperative period. However, the role of methadone as part of a multimodal analgesic regimen in minimally invasive lung resection surgery has not been well-defined. This randomized controlled trial aims to address this gap by directly comparing methadone-based analgesia to standard of care in patients undergoing elective minimally invasive lung resection surgery.
Wake Forest University Health Sciences is the lead sponsor of 1,350 studies on the registry; 203 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 250 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Analgesia with methadone. Other analgesic medications may also be given.
Drug: Methadone
Patients in the standard of care group may receive any analgesic at discretion of the anesthesia team but may not receive methadone.
Drug: Standard of Care
intraoperative methadone 0.1mg/kg on induction, based on actual body weight, maximum of 10 mg
any standard of care analgesic at discretion of the anesthesia team not including methadone
Morphine Milligram Equivalents-24
opioids received for the treatment of postoperative pain and converted to Morphine Milligram Equivalents equivalents between HR 0-24 during hospitalization
Time frame: Postoperative Hour 24
Morphine Milligram Equivalents-48
opioids received for the treatment of postoperative pain and converted to Morphine Milligram Equivalents (MME) between hour 24-48. If subjects have been discharged then only the available data will be used for conversion of MMEs.
Time frame: Postoperative Hour 48
Morphine Milligram Equivalents-72
opioids received for the treatment of postoperative pain and converted to Morphine Milligram Equivalents (MME) between hour 48-72. If subjects have been discharged then only the available data will be used for conversion of MMEs.
Time frame: Postoperative Hour 72
Pain Score
Participants will rate their pain level on a scale of 0-10 with 0 being no pain and 10 the worst imaginable pain.
Time frame: Postoperative Hour 24
Pain Score
Participants will rate their pain level on a scale of 0-10 with 0 being no pain and 10 the worst imaginable pain. If subjects have been discharged then only the available data will be used.
Time frame: Postoperative Hour 48
Pain Score
Participants will rate their pain level on a scale of 0-10 with 0 being no pain and 10 the worst imaginable pain. If subjects have been discharged then only the available data will be used.
Time frame: Postoperative Hour 72
Patient Satisfaction Score
Patients will be asked to rate their satisfaction on a scale of 0-10 with 0 being completely dissatisfied and 10 being completely satisfied at hours 24, 48, and 72 (if not discharged )
Time frame: Postoperative hours 24, 48, 72
Number of Patients with Respiratory Complications
Number of patients with documented respiratory complications- including hypoxia, reintubation, receiving naloxone, hypoventilation, acute renal failure, myocardial infarction, ileus, and mortality. Evaluated at timepoints of occurrence of 0-24, 24-48, and 48-72 (or discharge)
Time frame: Postoperative hour 24, 48, 72
Pain Scores at Month 3 and Month 6
Participants will rate their pain level on a scale of 0-10 with 0 being no pain and 10 the worst imaginable pain.
Time frame: Postoperative Month 3 and Month 6
Percentage of subjects with opioid use at Month 3 and Month 6
participants will self report on phone contact the continued use of opioids for the treatment of residual surgical pain at 3 and 6 months postoperatively
Time frame: 6 months
Other open studies at Atrium Health Wake Forest Baptist, Winston-Salem
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Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methadone
Agnosia
Wake Forest University Health Sciences →