Pain ManagementPhase 4NCT07914751
Methadone Versus Standard of Care for Pain Control in Minimally Invasive Lung Resection Surgery
A Phase 4 study testing Methadone in people with Pain Management, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for minimally-invasive lung resection surgery (for example, wedge, lobe, segmentectomy, combination of aforementioned procedures)
- Elective same day admission cases Exclusion Criteria
- Daily use of >/= 60 MME for 1 month or greater
- Weight < 50 kg
- Baseline oxygen requirement
- Chronic Kidney Disease Stage 4 or 5
Show all 9Show fewer
- Diagnosis of cirrhosis or liver failure
- Left ventricular ejection fraction < 30%
- Conversion to thoracotomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
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.
- Conditions
- Pain Management
- Being tested
- Methadone, Standard of Care
- Keywords
- minimally invasive, thoracic surgery, thoracic anesthesia, methadone
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
intraoperative methadone 0.1mg/kg on induction, based on actual body weight, maximum of 10 mg
Standard of CareDrug
any standard of care analgesic at discretion of the anesthesia team not including methadone
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | Analgesia with methadone. Other analgesic medications may also be given. Receives: Drug: Methadone |
| Standard of Care | Active comparator | Patients in the standard of care group may receive any analgesic at discretion of the anesthesia team but may not receive methadone. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Hour 72
Secondary outcomes (4)
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 )
Measured: 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)
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rohesh Fernando, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914751
- Sponsor's protocol ID
- IRB00155968
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Versus Standard of Care for Pain Control in Minimally Invasive Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT07914751
- Acronym / sponsor ID
- IRB00155968
- Conditions
- Pain Management
- Keywords
- minimally invasive, thoracic surgery, thoracic anesthesia, methadone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: MethadoneAnalgesia with methadone. Other analgesic medications may also be given. |
| Standard of Care | Active comparator | Drug: Standard of CarePatients in the standard of care group may receive any analgesic at discretion of the anesthesia team but may not receive methadone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled for minimally-invasive lung resection surgery (for example, wedge, lobe, segmentectomy, combination of aforementioned procedures)
- Elective same day admission cases Exclusion Criteria
- Daily use of >/= 60 MME for 1 month or greater
- Weight < 50 kg
- Baseline oxygen requirement
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadoneintraoperative methadone 0.1mg/kg on induction, based on actual body weight, maximum of 10 mg | Drug | Methadone |
| Standard of Careany standard of care analgesic at discretion of the anesthesia team not including methadone | Drug | Standard of Care |
Primary outcome
Morphine Milligram Equivalents-24
Time frame: Postoperative Hour 24
opioids received for the treatment of postoperative pain and converted to Morphine Milligram Equivalents equivalents between HR 0-24 during hospitalization
Morphine Milligram Equivalents-48
Time frame: Postoperative Hour 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.
Morphine Milligram Equivalents-72
Time frame: Postoperative Hour 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.
Pain Score
Time frame: Postoperative Hour 24
Participants will rate their pain level on a scale of 0-10 with 0 being no pain and 10 the worst imaginable pain.
Pain Score
Time frame: Postoperative Hour 48
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.
Pain Score
Time frame: Postoperative Hour 72
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.
4 secondary outcomes
Patient Satisfaction Score
Time frame: Postoperative hours 24, 48, 72
Number of Patients with Respiratory Complications
Time frame: Postoperative hour 24, 48, 72
Pain Scores at Month 3 and Month 6
Time frame: Postoperative Month 3 and Month 6
Percentage of subjects with opioid use at Month 3 and Month 6
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rohesh Fernando, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone in people with Pain Management, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rohesh Fernando, MD (336-716-4498, rohesh.fernando@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalents-24 (time frame: Postoperative Hour 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.