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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Group receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery. |
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| Routine | No Intervention | Group that receives routine anesthesia with opioid medications during complex spine surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone-dexmedetomidine-ketamine combination | Drug | Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
Additional screening measures:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Columbia | Missouri | 65212 | United States |
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| 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 |