Trial · NCT04220489
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
NCT04220489, Phase 2, Terminated, Jacques E. Chelly; results first posted 2024-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery. Trials, record NCT04220489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04220489
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
- NCT number
- NCT04220489
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Jacques E. Chelly
- Conditions
- Opioid Dependence, Chronic Pain
- Interventions
- Ketamine, Placebo Comparator
- First posted
- 2020-01-07
- Last updated
- 2024-01-30
- Results first posted
- 2024-01-30
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization | 72 hours postoperatively | 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. |
| Primary | Post-surgical Pain Rating Using the Visual Analog Scale (VAS) | 72 hours post-operatively | Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. Pain will be monitored every four hours from the time the participant enters the PACU until discharge from the hospital, except during the night when the participant is asleep. The value reported consists of the average of all pain scores collected. |
| Primary | Post-surgical Opioid Utilization Using Electronic Medication Review | 72 hours post-operatively | Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes. |
| Primary | Post-surgical Opioid Utilization Using Electronic Medication Review | 6-week follow-up visit | Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes. |
| Primary | Pre-surgical Opioid Utilization Using the Pain Medication Review Form | Screening visit | Pre-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking. |
| Primary | Pre-surgical Pain Rating Using the Visual Analog Scale (VAS) | Screening visit | Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores present a worse outcome. |
| Secondary | Pre-surgical Emotional Distress Related to Depression | Screening visit | Pre-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome. |
| Secondary | Post-surgical Emotional Distress Related to Depression | Day 10-14 Post-Operative Visit | Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome. The value reported consists of the average of all questionnaire scores collected between POD 10 and POD 14. |
| Secondary | Post-surgical Emotional Distress Related to Depression | 6-week follow-up visit | Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome. |
| Secondary | Pre-surgical Emotional Distress Related to Anxiety | Screening visit | Pre-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization | 72 hours postoperatively | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | mg morphine equivalents per 24 hours | MEAN |
| PRIMARY | Post-surgical Pain Rating Using the Visual Analog Scale (VAS) | 72 hours post-operatively | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | units on a scale | MEAN |
| PRIMARY | Post-surgical Opioid Utilization Using Electronic Medication Review | 72 hours post-operatively | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | mg morphine equivalents per 24 hours | MEAN |
| PRIMARY | Post-surgical Opioid Utilization Using Electronic Medication Review | 6-week follow-up visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | mg | MEAN |
| PRIMARY | Pre-surgical Opioid Utilization Using the Pain Medication Review Form | Screening visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | count of prescription medications | MEAN |
| PRIMARY | Pre-surgical Pain Rating Using the Visual Analog Scale (VAS) | Screening visit | Data was not collected | ||
| SECONDARY | Pre-surgical Emotional Distress Related to Depression | Screening visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | score on a scale | MEAN |
| SECONDARY | Post-surgical Emotional Distress Related to Depression | Day 10-14 Post-Operative Visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | score on a scale | MEAN |
| SECONDARY | Post-surgical Emotional Distress Related to Depression | 6-week follow-up visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | score on a scale | MEAN |
| SECONDARY | Pre-surgical Emotional Distress Related to Anxiety | Screening visit | Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group | score on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization | Ketamine Group | 40 | Standard Deviation 0 | mg morphine equivalents per 24 hours | |
| Post-surgical Pain Rating Using the Visual Analog Scale (VAS) | Ketamine Group | 5 | Standard Deviation 0 | units on a scale | |
| Post-surgical Opioid Utilization Using Electronic Medication Review | Ketamine Group | 40 | Standard Deviation 0 | mg morphine equivalents per 24 hours | |
| Post-surgical Opioid Utilization Using Electronic Medication Review | Ketamine Group | 4 | Standard Deviation 0 | mg | |
| Pre-surgical Opioid Utilization Using the Pain Medication Review Form | Ketamine Group | 4 | Standard Deviation 0 | count of prescription medications | |
| Pre-surgical Emotional Distress Related to Depression | Ketamine Group | 27 | Standard Deviation 0 | score on a scale | |
| Post-surgical Emotional Distress Related to Depression | Ketamine Group | 14 | Standard Deviation 0 | score on a scale | |
| Post-surgical Emotional Distress Related to Depression | Ketamine Group | 19 | Standard Deviation 0 | score on a scale | |
| Pre-surgical Emotional Distress Related to Anxiety | Ketamine Group | 23 | Standard Deviation 0 | score on a scale | |
| Post-surgical Emotional Distress Related to Anxiety | Ketamine Group | 16 | Standard Deviation 0 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketamine Group | 1 | |
| Overall Study | STARTED | Placebo Group | 0 | |
| Overall Study | COMPLETED | Ketamine Group | 1 | |
| Overall Study | COMPLETED | Placebo Group | 0 | |
| Overall Study | NOT COMPLETED | Ketamine Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine Group | 0 | 1 |
| Total, all-cause mortality | Placebo Group | 0 | 0 |
| Total, other adverse events | Ketamine Group | 0 | 1 |
| Total, other adverse events | Placebo Group | 0 | 0 |
| Total, serious adverse events | Ketamine Group | 0 | 1 |
| Total, serious adverse events | Placebo Group | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04220489
GET https://conductscience.org/api/trials/v1/NCT04220489/registered