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NCT04220489 · ClinicalTrials.gov registry record · Phase 2
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
A Phase 2 study, sponsored by Jacques E. Chelly.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04220489: Clinical Trial Phase 2 study, sponsored by Jacques E. Chelly.
NCT04220489 is a Phase 2 study that was terminated before completion, run by Jacques E. Chelly. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04220489, a Phase 2 study, was terminated before completion, sponsored by Jacques E. Chelly.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo Opioid dependence will be defined as daily opioid use (2 or more doses per day) for a period of two-months or longer. Intraoperatively, patients will receive a 1 mg/kg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr or saline will be run to conclude at 24 hours after the end of the surgery (fascial closure). The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively. Secondary outcome measures will be VAS pain scores at rest and with movement in PACU, 24 hr, 48 hr, 72 hr, 2 week (post-op visit), 6 week follow-up visit, as well as, McGill Pain Questionnaire, Pain Catastrophizing Scale, and emotional distress surveys assessing depression and anxiety at preop/screening, postop and 6 week follow-up (PROMIS Emotional Distress-Anxiety Short Form, PROMIS Emotional Distress-Depression Short Form), as well as a Neuro-QOL Short Form v1.1 - Satisfaction with Social Roles and Activities .
Primary Outcome
Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Hydromorphone opioid usage will be assessed and converted to morphine equivalents/24 hour. The higher the values, the worse the outcomes.
Interventions
- DRUG Ketamine
- DRUG Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2022-11-19 |
| Phase | Phase 2 |
Why NCT04220489 stopped before completion
NCT04220489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT04220489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04220489 about?
NCT04220489 is a clinical study titled "Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery". The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when co...
What is the current status of trial NCT04220489?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-12-17. Estimated completion is 2022-11-19.
What interventions are being tested in trial NCT04220489?
The interventions under investigation include: Ketamine (DRUG), Placebo Comparator (DRUG).
Who is sponsoring clinical trial NCT04220489?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04220489's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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