TerminatedNCT05552443Updated May 14, 2026Results posted

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

A Phase 4 interventional study of Hydromorphone 2.5 mcg/kg and Hydromorphone 2.75 mcg/kg in Pain Control, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment

Why this study was terminated

Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.

Phase: Phase 4
Study type: Interventional
Enrollment: 31
Allocation: Non-randomized
Ages: 10 Years to 17 Years
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Pain Control

Browse trials for

Agnosia 1,190

Keywords

Posterior Spine Surgery
Pediatric Idiopathic Scoliosis Repair

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 31 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 10 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.

Exclusion criteria

Exclusion criteria:

Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 31 participants (actual)

Study arms

Experimental
Intrathecal Hydromorphone 2.5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 2.5 mcg/kg
Experimental
Intrathecal Hydromorphone 2.75 mcg/kg
Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 2.75 mcg/kg
Experimental
Intrathecal Hydromorphone 3 mcg/kg
Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 3 mcg/kg
Experimental
Intrathecal Hydromorphone 3.25 mcg/kg
Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 3.25 mcg/kg
Experimental
Intrathecal Hydromorphone 3.5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 3.5 mcg/kg
Experimental
Intrathecal Hydromorphone 4 mcg/kg
Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 4 mcg/kg
Experimental
Intrathecal Hydromorphone 4.5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 4.5 mcg/kg
Experimental
Intrathecal Hydromorphone 5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 5 mcg/kg
Experimental
Intrathecal Hydromorphone 5.5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 5.5 mcg/kg
Experimental
Intrathecal Hydromorphone 6 mcg/kg
Subjects undergoing posterior spinal surgery will receive 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 6 mcg/kg
Experimental
Intrathecal Hydromorphone 6.5 mcg/kg
Subjects undergoing posterior spinal surgery will receive 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 6.5 mcg/kg
Experimental
Intrathecal Hydromorphone 7 mcg/kg
Subjects undergoing posterior spinal surgery will receive 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Drug: Hydromorphone 7 mcg/kg

Interventions

DrugHydromorphone 2.5 mcg/kg
2.5 mcg/kg intrathecal
DrugHydromorphone 2.75 mcg/kg
2.75 mcg/kg intrathecal
DrugHydromorphone 3 mcg/kg
3 mcg/kg intrathecal
DrugHydromorphone 3.25 mcg/kg
3.25 mcg/kg intrathecal
DrugHydromorphone 3.5 mcg/kg
3.5 mcg/kg intrathecal
DrugHydromorphone 4 mcg/kg
4 mcg/kg intrathecal
DrugHydromorphone 4.5 mcg/kg
4.5 mcg/kg intrathecal
DrugHydromorphone 5 mcg/kg
5 mcg/kg intrathecal
DrugHydromorphone 5.5 mcg/kg
5.5 mcg/kg intrathecal
DrugHydromorphone 6 mcg/kg
6 mcg/kg intrathecal
DrugHydromorphone 6.5 mcg/kg
6.5 mcg/kg intrathecal
DrugHydromorphone 7 mcg/kg
7 mcg/kg intrathecal

What researchers measure

Primary outcomes

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.
Time frame: 18 hours after intrathecal hydromorphone administration

Secondary outcomes

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)).
Time frame: 24 postoperative hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 postoperative hours

Results

Posted May 14, 2026

Limitations and caveats

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.

Participant flow

There were 31 subjects consented to the study, one of which was withdrawn from the study before study group assignment occurred.

Participant flow — Overall Study
Milestone	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Started	2	1	1	3	4	5	6	8
Completed	2	1	1	3	4	3	6	7
Not completed	0	0	0	0	0	2	0	1
Withdrew: Physician decision	0	0	0	0	0	2	0	1

Outcome measures

PrimaryPain 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.

Time frame:: 18 hours after intrathecal hydromorphone administration
Reported as:: Median · pain score units*hours

Pain Intensity (Area Under the Curve Pain)
pain score units*hours	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Pain Intensity (Area Under the Curve Pain)	—	—	—	22.9 (20.7 to 25.1)	17.8 (17.8 to 17.8)	18.0 (18.0 to 18.0)	17.2 (9.2 to 38.8)	4.1 (0.0 to 36.6)	50.0 (25.2 to 54.8)	37.6 (19.3 to 86.2)	27.5 (13.4 to 45.5)

SecondaryNumber 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)).

Time frame:: 24 postoperative hours
Reported as:: Count of participants · Participants

Number of Subjects Needing Dual Anti-pruritic Agents
Participants	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Number of Subjects Needing Dual Anti-pruritic Agents	—	—	—	1	1	0	1	2	1	1	1

SecondaryMaximum 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.

Time frame:: 18 hours after intrathecal hydromorphone administration
Reported as:: Median · score on a scale

Maximum Pain Scores
score on a scale	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Maximum Pain Scores	—	—	—	5.5 (4 to 7)	6.0 (6 to 6)	7.0 (7 to 7)	3.0 (3 to 7)	4.5 (0 to 5)	4.0 (3 to 5)	6.5 (4 to 8)	5.0 (1 to 8)

SecondaryOral 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.

Time frame:: 24 hours after intrathecal hydromorphone administration
Reported as:: Mean · mg

Oral Morphine Equivalents Consumption
mg	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Oral Morphine Equivalents Consumption	—	—	—	131 (126 to 135)	163 (163 to 163)	143 (143 to 143)	193 (153 to 258)	191 (171 to 240)	232 (222 to 237)	240 (197 to 285)	228 (174 to 263)

SecondaryNumber of Subjects Needing Antiemetic Medications Postoperatively

The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting.

Time frame:: 24 postoperative hours
Reported as:: Count of participants · Participants

Number of Subjects Needing Antiemetic Medications Postoperatively
Participants	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Number of Subjects Needing Antiemetic Medications Postoperatively	—	—	—	1	1	1	2	4	1	4	5

Adverse events

Collected over Adverse events were collected from the time of informed consent through study completion, approximately 24 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intrathecal Hydromorphone 2.5 mcg/kg	—	—	—
Intrathecal Hydromorphone 2.75 mcg/kg	—	—	—
Intrathecal Hydromorphone 3 mcg/kg	—	—	—
Intrathecal Hydromorphone 3.25 mcg/kg	—	—	—
Intrathecal Hydromorphone 3.5 mcg/kg	0/2 (0%)	0/2 (0%)	0/2 (0%)
Intrathecal Hydromorphone 4 mcg/kg	0/1 (0%)	0/1 (0%)	1/1 (100%)
Intrathecal Hydromorphone 4.5 mcg/kg	0/1 (0%)	0/1 (0%)	0/1 (0%)
Intrathecal Hydromorphone 5 mcg/kg	0/3 (0%)	0/3 (0%)	0/3 (0%)
Intrathecal Hydromorphone 5.5 mcg/kg	0/4 (0%)	0/4 (0%)	1/4 (25%)
Intrathecal Hydromorphone 6 mcg/kg	0/5 (0%)	0/5 (0%)	1/5 (20%)
Intrathecal Hydromorphone 6.5 mcg/kg	0/6 (0%)	0/6 (0%)	0/6 (0%)
Intrathecal Hydromorphone 7 mcg/kg	0/8 (0%)	0/8 (0%)	1/8 (12.5%)

Most frequent other events

Most frequent other events
Event	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg
Airway TraumaInjury, poisoning and procedural complications	—	—	—	—	0/2	1/1	0/1	0/3	0/4	0/5	0/6	0/8
Prolonged Sedation due to Inability to Meet Extubation CriteriaInjury, poisoning and procedural complications	—	—	—	—	0/2	0/1	0/1	0/3	1/4	0/5	0/6	0/8
DesaturationsInjury, poisoning and procedural complications	—	—	—	—	0/2	0/1	0/1	0/3	0/4	1/5	0/6	1/8
ApneasInjury, poisoning and procedural complications	—	—	—	—	0/2	0/1	0/1	0/3	0/4	0/5	0/6	1/8
Nausea/VomitingGastrointestinal disorders	—	—	—	—	0/2	0/1	0/1	0/3	0/4	0/5	0/6	1/8

Baseline characteristics

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.

Age, Categorical
Age, Categorical(Participants)	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg	Total
<=18 years	—	—	—	—	2	1	1	3	4	5	6	8	30
Between 18 and 65 years	—	—	—	—	0	0	0	0	0	0	0	0	0
>=65 years	—	—	—	—	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg	Total
Female	—	—	—	—	2	0	1	3	2	3	6	4	21
Male	—	—	—	—	0	1	0	0	2	2	0	4	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg	Total
Hispanic or Latino	—	—	—	—	0	0	0	0	0	1	0	0	1
Not Hispanic or Latino	—	—	—	—	2	1	1	3	4	4	6	8	29
Unknown or Not Reported	—	—	—	—	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg	Total
American Indian or Alaska Native	—	—	—	—	0	0	0	0	0	0	0	0	0
Asian	—	—	—	—	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	—	—	—	—	0	0	0	0	0	0	0	0	0
Black or African American	—	—	—	—	0	0	0	0	2	0	2	0	4
White	—	—	—	—	2	1	1	3	2	5	4	8	26
More than one race	—	—	—	—	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	—	—	—	—	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Intrathecal Hydromorphone 2.5 mcg/kg	Intrathecal Hydromorphone 2.75 mcg/kg	Intrathecal Hydromorphone 3 mcg/kg	Intrathecal Hydromorphone 3.25 mcg/kg	Intrathecal Hydromorphone 3.5 mcg/kg	Intrathecal Hydromorphone 4 mcg/kg	Intrathecal Hydromorphone 4.5 mcg/kg	Intrathecal Hydromorphone 5 mcg/kg	Intrathecal Hydromorphone 5.5 mcg/kg	Intrathecal Hydromorphone 6 mcg/kg	Intrathecal Hydromorphone 6.5 mcg/kg	Intrathecal Hydromorphone 7 mcg/kg	Total
United States	—	—	—	—	2	1	1	3	4	5	5	8	29
Canada	—	—	—	—	0	0	0	0	0	0	1	0	1

Study locations

1 site

Mayo Clinic Rochester
Rochester, Minnesota 55905, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05552443
Lead sponsor: Mayo Clinic
Responsible party: Kathryn (Katie) S. Handlogten (Principal Investigator, Mayo Clinic) — Principal investigator
First posted: Sep 23, 2022
Start date: Mar 23, 2023
Primary completion: Oct 27, 2024
Completion: Dec 31, 2024
Results posted: May 14, 2026
Last update: May 14, 2026

Study contacts

Kathryn Handlogten, MD

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Agnosia→

Other studies from this sponsor

Mayo Clinic

Start the discussion