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NCT02827526 · ClinicalTrials.gov registry record · Phase 4
Methadone and Ketamine for Spinal Surgery
A Phase 4 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT02827526 is a Phase 4 study that has completed, run by Endeavor Health. The registered enrollment target is 130 participants.
The verdict
NCT02827526, a Phase 4 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Several factors contribute to postoperative pain in this patient population. Many patients present to surgery dependent on relatively high doses of oral opioids; this daily administration leads to tolerance to the effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which leads to fluctuations in levels of pain control (patients have to push a button to deliver pain medication when they begin to feel discomfort). Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after spinal fusion surgery. However, other pain treatment modalities are required in this patient population. Studies have demonstrated that ketamine, a drug that prevents pain by a mechanism different from opioids, is effective in reducing pain medication requirements when given in the perioperative period. Small-dose infusions not only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular, the combination of methadone and ketamine may be especially effective in controlling pain in patients following major operations. The aim of this randomized clinical trial is to examine the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the operating room, on postoperative pain medication requirements, pain scores, and clinical recovery characteristics after spinal fusion surgery.
Interventions
- DRUG Ketamine
- DRUG Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2016-07 |
| Est. Completion | 2021-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02827526
The ClinicalTrials.gov registry entry for NCT02827526 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT02827526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02827526 about?
NCT02827526 is a clinical study titled "Methadone and Ketamine for Spinal Surgery". Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Several factors contribute to postoperative pain in this patient population. Many patients present to surgery dependent on relatively high doses of ora...
What is the current status of trial NCT02827526?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2016-07. Estimated completion is 2021-02.
What interventions are being tested in trial NCT02827526?
The interventions under investigation include: Ketamine (DRUG), Control (DRUG).
Who is sponsoring clinical trial NCT02827526?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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