Spine SurgeryPhase 4NCT07365800
The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.
A Phase 4 study testing Methadone-dexmedetomidine-ketamine combination in people with Spine Surgery, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study will investigate whether a combination of three anesthetic medications will reduce intraoperative and postoperative pain in patients undergoing complex spine surgery, and whether it will reduce the use of opioid pain medication after surgery. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Methadone-dexmedetomidine-ketamine combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to Jun 2027
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-79 years of age
- Patients undergoing complex spine surgery, defined as 3 or more levels
- English-speaking
- Able to consent for themselves
Who cannot join
- Patients who are unable to consent to study participation in English
- Patients who are unable to consent for themselves.
- Patients with prolonged QT syndrome
- Pregnancy
- Additional screening measures:
- Preoperative ECG will be performed in preoperative holding as part of standard of care to assess for prolonged QTc prior to administration of methadone as part of SOC.
- Pregnancy test will be performed as part of SOC on the day of surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will investigate whether a combination of three anesthetic medications will reduce intraoperative and postoperative pain in patients undergoing complex spine surgery, and whether it will reduce the use of opioid pain medication after surgery.
Read the detailed description
Dexmedetomidine, methadone and ketamine offer benefits when used as adjuncts in complex spine surgeries. Dexmedetomidine is reported to attenuate intraoperative stress responses without interfering with neuromonitoring while potentially improving postoperative pain control and reducing opioid consumption in complex spine surgery. Methadone use intraoperatively improves postoperative pain control and reduced opioid requirements following complex spine surgery. Consensus guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists support the use of ketamine in acute pain management in surgeries like spine surgery. Perioperative ketamine use in spine surgery results in lower pain scores and reduced opioid utilization postoperatively. The use of dexmedetomidine, methadone and ketamine as adjuncts may improve postoperative pain control while reducing opioid requirements, lowering stress responses, and without significantly impacting neuromonitoring in complex spine surgery or increasing drug related adverse events.
- Conditions
- Spine Surgery
- Being tested
- Methadone-dexmedetomidine-ketamine combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone-dexmedetomidine-ketamine combinationDrug
Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery. Receives: Drug: Methadone-dexmedetomidine-ketamine combination |
| Routine | No intervention | Group that receives routine anesthesia with opioid medications during complex spine surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the MDK combination during surgery on postoperative opioid consumption
Determine if use of dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on postoperative opioid consumption following complex spine surgery of 3 or more levels
Measured: 72 hours postoperatively
Secondary outcomes (2)
Effect of MDK combination on overall postoperative pain scores.
Determine whether dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on overall postoperative pain scores following complex spine surgery compared to standard therapy. Pain scores using the visual analog scale, collected by nursing staff during hospital stay, will be used.
Measured: 72 hours after surgery
Incidence of opioid-related adverse events
Evaluate incidence of opioid related adverse events in patients treated with intraoperative combination of methadone, dexmedetomidine and ketamine compared to standard therapy. The number of adverse events per group will be collected.
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start24 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoinette Burger, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365800
- Sponsor's protocol ID
- 2130514
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.
- ClinicalTrials.gov ID
- NCT07365800
- Acronym / sponsor ID
- 2130514
- Conditions
- Spine Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jan 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 will investigate whether a combination of three anesthetic medications will reduce intraoperative and postoperative pain in patients undergoing complex spine surgery, and whether it will reduce the use of opioid pain medication after surgery.
Detailed description
Dexmedetomidine, methadone and ketamine offer benefits when used as adjuncts in complex spine surgeries. Dexmedetomidine is reported to attenuate intraoperative stress responses without interfering with neuromonitoring while potentially improving postoperative pain control and reducing opioid consumption in complex spine surgery. Methadone use intraoperatively improves postoperative pain control and reduced opioid requirements following complex spine surgery. Consensus guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists support the use of ketamine in acute pain management in surgeries like spine surgery. Perioperative ketamine use in spine surgery results in lower pain scores and reduced opioid utilization postoperatively. The use of dexmedetomidine, methadone and ketamine as adjuncts may improve postoperative pain control while reducing opioid requirements, lowering stress responses, and without significantly impacting neuromonitoring in complex spine surgery or increasing drug related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Methadone-dexmedetomidine-ketamine combinationGroup receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery. |
| Routine | No intervention | –Group that receives routine anesthesia with opioid medications during complex spine surgery. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-79 years of age
- Patients undergoing complex spine surgery, defined as 3 or more levels
- English-speaking
- Able to consent for themselves
Key exclusion criteria (7 listed)
- Patients who are unable to consent to study participation in English
- Patients who are unable to consent for themselves.
- Patients with prolonged QT syndrome
- Pregnancy
- Preoperative ECG will be performed in preoperative holding as part of standard of care to assess for prolonged QTc prior to administration of methadone as part of SOC.
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 |
|---|---|---|
| Methadone-dexmedetomidine-ketamine combinationCombination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management. | Drug | Intervention |
Primary outcome
Effect of the MDK combination during surgery on postoperative opioid consumption
Time frame: 72 hours postoperatively
Determine if use of dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on postoperative opioid consumption following complex spine surgery of 3 or more levels
2 secondary outcomes
Effect of MDK combination on overall postoperative pain scores.
Time frame: 72 hours after surgery
Incidence of opioid-related adverse events
Time frame: 72 hours postoperatively
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 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
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.
The record lists no contact. Use the official record to reach the sponsor.
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-dexmedetomidine-ketamine combination in people with Spine Surgery, run by University of Missouri-Columbia 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 11 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the MDK combination during surgery on postoperative opioid consumption (time frame: 72 hours postoperatively). 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 11 Jun 2026.