The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone-dexmedetomidine-ketamine combination.
- Who it may be relevant to
- Registry conditions: Spine Surgery. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Methadone-dexmedetomidine-ketamine combination
Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management.
Primary outcome measures
- Effect of the MDK combination during surgery on postoperative opioid consumption [Time frame: 72 hours postoperatively]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Hospital — Columbia
Identifiers
NCT: NCT07365800 · 2130514