The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery
• Intervention / Treatment: Drug: Methadone-dexmedetomidine-ketamine combination

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 Type: Interventional
• Enrollment (Estimated): 248
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antoinette Burger, PhD; Phone Number: 5738843740; Email: aburger@health.missouri.edu
• Study Contact Backup: Name: Kiersten Norby, MD

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University Hospital
      • Contact: Antoinette Burger, PhD; Phone Number: 5738843740; Email: aburger@health.missouri.edu
      • Principal Investigator: Kiersten Norby, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age 18-79 years of age
• Patients undergoing complex spine surgery, defined as 3 or more levels
• English-speaking
• Able to consent for themselves

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Group receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery.	Drug: Methadone-dexmedetomidine-ketamine combination; Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management.
No Intervention: Routine; Group that receives routine anesthesia with opioid medications during complex spine surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	72 hours postoperatively

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2130514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes