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

NCT07365800 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2130514
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effect of MDK combination on overall postoperative pain scores.

  72 hours after surgery

• Incidence of opioid-related adverse events

  72 hours postoperatively

Study Arms (2)

Intervention

EXPERIMENTAL

Group receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery.

Drug: Methadone-dexmedetomidine-ketamine combination

Routine

NO INTERVENTION

Group that receives routine anesthesia with opioid medications during complex spine surgery.

Interventions

Methadone-dexmedetomidine-ketamine combination DRUG

Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management.

Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

Central Study Contacts

Antoinette Burger, PhD

CONTACT

5738843740; aburger@health.missouri.edu

Kiersten Norby, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 26, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)