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Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.
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The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. Each patient was assigned to a weight-based dose arm, between 3.5mcg/kg-7.0mcg/kg or up to a maximum of 400 mcg. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level.
ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was >5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Hydromorphone 2.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 2.75 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 3 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 3.25 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 3.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone 2.5 mcg/kg | Drug | 2.5 mcg/kg intrathecal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (Area Under the Curve Pain) | Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule. | 18 hours after intrathecal hydromorphone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Needing Dual Anti-pruritic Agents | The number of subjects who needed dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min)). | 24 postoperative hours |
| Maximum Pain Scores |
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Inclusion Criteria:
- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Handlogten, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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0 in 2.5-3.25mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. Adjustments made in 0.5mcg/kg increments based on efficacy defined asNRS≤5 within18hrs post-ITH. If subject had NRS>5,the next subject received next higher dose.If subject had NRS≤5,next subject had0.89 chance of receiving same dose and0.11 chance of receiving next lower dose.
There were 31 subjects consented to the study, one of which was withdrawn from the study before study group assignment occurred.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrathecal Hydromorphone 2.5 mcg/kg | Subjects undergoing posterior spinal surgery received 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.5 mcg/kg: 2.5 mcg/kg intrathecal |
| FG001 | Intrathecal Hydromorphone 2.75 mcg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2023 |
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|
| Intrathecal Hydromorphone 4 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 4.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 5.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 6 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 6.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Intrathecal Hydromorphone 7 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
|
| Hydromorphone 2.75 mcg/kg |
| Drug |
2.75 mcg/kg intrathecal |
|
| Hydromorphone 3 mcg/kg | Drug | 3 mcg/kg intrathecal |
|
| Hydromorphone 3.25 mcg/kg | Drug | 3.25 mcg/kg intrathecal |
|
| Hydromorphone 3.5 mcg/kg | Drug | 3.5 mcg/kg intrathecal |
|
| Hydromorphone 4 mcg/kg | Drug | 4 mcg/kg intrathecal |
|
| Hydromorphone 4.5 mcg/kg | Drug | 4.5 mcg/kg intrathecal |
|
| Hydromorphone 5 mcg/kg | Drug | 5 mcg/kg intrathecal |
|
| Hydromorphone 5.5 mcg/kg | Drug | 5.5 mcg/kg intrathecal |
|
| Hydromorphone 6 mcg/kg | Drug | 6 mcg/kg intrathecal |
|
| Hydromorphone 6.5 mcg/kg | Drug | 6.5 mcg/kg intrathecal |
|
| Hydromorphone 7 mcg/kg | Drug | 7 mcg/kg intrathecal |
|
Highest pain score reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with total scores ranging from 0=no pain and 10=worst pain ever with higher scores indicating more severe pain.
| 18 hours after intrathecal hydromorphone administration |
| Oral Morphine Equivalents Consumption | Total oral morphine equivalents (OME) consumption in the first 24 hours after intrathecal hydromorphone administration. Intrathecal hydromorphone will be included in total oral morphine equivalents consumption. | 24 hours after intrathecal hydromorphone administration |
| Number of Subjects Needing Antiemetic Medications Postoperatively | The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting. | 24 postoperative hours |
Subjects undergoing posterior spinal surgery received 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.75 mcg/kg: 2.75 mcg/kg intrathecal |
| FG002 | Intrathecal Hydromorphone 3 mcg/kg | Subjects undergoing posterior spinal surgery received 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3 mcg/kg: 3 mcg/kg intrathecal |
| FG003 | Intrathecal Hydromorphone 3.25 mcg/kg | Subjects undergoing posterior spinal surgery received 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.25 mcg/kg: 3.25 mcg/kg intrathecal |
| FG004 | Intrathecal Hydromorphone 3.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.5 mcg/kg: 3.5 mcg/kg intrathecal |
| FG005 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4 mcg/kg: 4 mcg/kg intrathecal |
| FG006 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4.5 mcg/kg: 4.5 mcg/kg intrathecal |
| FG007 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5 mcg/kg: 5 mcg/kg intrathecal |
| FG008 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5.5 mcg/kg: 5.5 mcg/kg intrathecal |
| FG009 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6 mcg/kg: 6 mcg/kg intrathecal |
| FG010 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6.5 mcg/kg: 6.5 mcg/kg intrathecal |
| FG011 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 7 mcg/kg: 7 mcg/kg intrathecal |
| COMPLETED |
|
| NOT COMPLETED |
|
|
0 in 2.5-3.25mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. Adjustments made in 0.5mcg/kg increments based on efficacy defined asNRS≤5 within18hrs post-ITH. If subject had NRS>5,the next subject received next higher dose.If subject had NRS≤5,next subject had0.89 chance of receiving same dose and0.11 chance of receiving next lower dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intrathecal Hydromorphone 2.5 mcg/kg | Subjects undergoing posterior spinal surgery received 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.5 mcg/kg: 2.5 mcg/kg intrathecal |
| BG001 | Intrathecal Hydromorphone 2.75 mcg/kg | Subjects undergoing posterior spinal surgery received 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.75 mcg/kg: 2.75 mcg/kg intrathecal |
| BG002 | Intrathecal Hydromorphone 3 mcg/kg | Subjects undergoing posterior spinal surgery received 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3 mcg/kg: 3 mcg/kg intrathecal |
| BG003 | Intrathecal Hydromorphone 3.25 mcg/kg | Subjects undergoing posterior spinal surgery received 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.25 mcg/kg: 3.25 mcg/kg intrathecal |
| BG004 | Intrathecal Hydromorphone 3.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.5 mcg/kg: 3.5 mcg/kg intrathecal |
| BG005 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4 mcg/kg: 4 mcg/kg intrathecal |
| BG006 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4.5 mcg/kg: 4.5 mcg/kg intrathecal |
| BG007 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5 mcg/kg: 5 mcg/kg intrathecal |
| BG008 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5.5 mcg/kg: 5.5 mcg/kg intrathecal |
| BG009 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6 mcg/kg:6 mcg/kg intrathecal |
| BG010 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6.5 mcg/kg:6.5 mcg/kg intrathecal |
| BG011 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 7 mcg/kg:7 mcg/kg intrathecal |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity (Area Under the Curve Pain) | Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule. | 0 in 2.5-3.0 mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. | Posted | Median | Full Range | pain score units*hours | 18 hours after intrathecal hydromorphone administration |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Needing Dual Anti-pruritic Agents | The number of subjects who needed dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min)). | 0 in 2.5-3.0 mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. | Posted | Count of Participants | Participants | 24 postoperative hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Pain Scores | Highest pain score reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with total scores ranging from 0=no pain and 10=worst pain ever with higher scores indicating more severe pain. | 0 in 2.5-3.0 mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. | Posted | Median | Full Range | score on a scale | 18 hours after intrathecal hydromorphone administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Oral Morphine Equivalents Consumption | Total oral morphine equivalents (OME) consumption in the first 24 hours after intrathecal hydromorphone administration. Intrathecal hydromorphone will be included in total oral morphine equivalents consumption. | 0 in 2.5-3.0 mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. | Posted | Mean | Full Range | mg | 24 hours after intrathecal hydromorphone administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Needing Antiemetic Medications Postoperatively | The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting. | 0 in 2.5-3.0 mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. | Posted | Count of Participants | Participants | 24 postoperative hours |
|
Adverse events were collected from the time of informed consent through study completion, approximately 24 hours.
0 in 2.5-3.25mcg/kg arms as SDMS didn't assign subjects to those doses due to ITH dose for 1st subject being 3.5mcg/kg and subsequent subjects dose assignmts following a biased-coin up-down sequential allocation design. Adjustments made in 0.5mcg/kg increments based on efficacy defined asNRS≤5 within18hrs post-ITH. If subject had NRS>5,the next subject received next higher dose.If subject had NRS≤5,next subject had0.89 chance of receiving same dose and0.11 chance of receiving next lower dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrathecal Hydromorphone 2.5 mcg/kg | Subjects undergoing posterior spinal surgery received 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.5 mcg/kg: 2.5 mcg/kg intrathecal | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Intrathecal Hydromorphone 2.75 mcg/kg | Subjects undergoing posterior spinal surgery received 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 2.75 mcg/kg: 2.75 mcg/kg intrathecal | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Intrathecal Hydromorphone 3 mcg/kg | Subjects undergoing posterior spinal surgery received 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3 mcg/kg: 3 mcg/kg intrathecal | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Intrathecal Hydromorphone 3.25 mcg/kg | Subjects undergoing posterior spinal surgery received 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.25 mcg/kg: 3.25 mcg/kg intrathecal | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Intrathecal Hydromorphone 3.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 3.5 mcg/kg: 3.5 mcg/kg intrathecal | 0 | 2 | 0 | 2 | 0 | 2 |
| EG005 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4 mcg/kg: 4 mcg/kg intrathecal | 0 | 1 | 0 | 1 | 1 | 1 |
| EG006 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 4.5 mcg/kg: 4.5 mcg/kg intrathecal | 0 | 1 | 0 | 1 | 0 | 1 |
| EG007 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5 mcg/kg: 5 mcg/kg intrathecal | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 5.5 mcg/kg: 5.5 mcg/kg intrathecal | 0 | 4 | 0 | 4 | 1 | 4 |
| EG009 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6 mcg/kg: 6 mcg/kg intrathecal | 0 | 5 | 0 | 5 | 1 | 5 |
| EG010 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 6.5 mcg/kg: 6.5 mcg/kg intrathecal | 0 | 6 | 0 | 6 | 0 | 6 |
| EG011 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Hydromorphone 7 mcg/kg: 7 mcg/kg intrathecal | 0 | 8 | 0 | 8 | 1 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Airway Trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Desaturations | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Apneas | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Prolonged Sedation due to Inability to Meet Extubation Criteria | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
This study was terminated early as a study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Handlogten, M.D. | Mayo Clinic | 507-255-4236 | handlogten.kathryn@mayo.edu |
| Jan 13, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG004 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG005 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG006 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG007 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG008 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG009 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG010 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
|
|
| OG003 | Intrathecal Hydromorphone 3.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG004 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG005 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG006 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG007 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG008 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG009 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG010 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
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| OG003 |
| Intrathecal Hydromorphone 3.5 mcg/kg |
Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG004 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG005 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG006 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG007 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG008 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG009 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG010 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
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Subjects undergoing posterior spinal surgery received 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG004 | Intrathecal Hydromorphone 4 mcg/kg | Subjects undergoing posterior spinal surgery received 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG005 | Intrathecal Hydromorphone 4.5 mcg/kg | Subjects undergoing posterior spinal surgery received 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG006 | Intrathecal Hydromorphone 5 mcg/kg | Subjects undergoing posterior spinal surgery received 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG007 | Intrathecal Hydromorphone 5.5 mcg/kg | Subjects undergoing posterior spinal surgery received 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG008 | Intrathecal Hydromorphone 6 mcg/kg | Subjects undergoing posterior spinal surgery received 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG009 | Intrathecal Hydromorphone 6.5 mcg/kg | Subjects undergoing posterior spinal surgery received 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
| OG010 | Intrathecal Hydromorphone 7 mcg/kg | Subjects undergoing posterior spinal surgery received 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level. |
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