40 Participants Needed

Intrathecal Hydromorphone for Pain Management in Scoliosis Repair

H
Overseen ByHandlogten
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used opioids before surgery. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug hydromorphone for pain management in scoliosis repair?

Research shows that hydromorphone, when used in epidurals, has been effective for pain relief after spinal fusion surgery in patients with scoliosis. It has been used as part of a pain management plan to help control severe postoperative pain.12345

Is intrathecal hydromorphone safe for pain management in humans?

Intrathecal hydromorphone has been used safely for pain management in various conditions, such as after cesarean delivery, where it provided effective pain relief with fewer side effects compared to other opioids. Additionally, hydromorphone has been used in epidural form for pain management after spinal surgeries, indicating its general safety in humans.12456

How is the drug hydromorphone unique for pain management in scoliosis repair?

Intrathecal hydromorphone is unique because it is administered directly into the spinal fluid, potentially providing more consistent pain relief with fewer side effects compared to other opioids like morphine, which are commonly used but can have varying effectiveness due to differences in how they dissolve in fat.12356

What is the purpose of this trial?

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.

Research Team

KH

Kathryn Handlogten, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for children undergoing spinal surgery for idiopathic scoliosis. They must not have high pre-surgery pain scores, a history of chronic pain or opioid use, and no risk factors that make spinal anesthesia unsafe like certain anatomical abnormalities or increased bleeding/infection risks.

Inclusion Criteria

I am having back surgery for scoliosis through an approach from the back.

Exclusion Criteria

I do not have conditions that make spinal anesthesia risky for me.
I do not have chronic pain, haven't used opioids before surgery, and my pain score is below 3.
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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intrathecal hydromorphone at varying doses to determine the optimal analgesic dose for pain control during posterior spine surgery

1 day
1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for pain intensity and side effects such as pruritus and nausea within the first 24 hours after intrathecal hydromorphone administration

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Hydromorphone
Trial Overview The study is testing different doses of intrathecal hydromorphone (an opioid pain medication) to find the best balance between effective pain control and minimal side effects in pediatric patients after scoliosis repair surgery.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Intrathecal Hydromorphone 5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group II: Intrathecal Hydromorphone 4.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group III: Intrathecal Hydromorphone 4 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group IV: Intrathecal Hydromorphone 3.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group V: Intrathecal Hydromorphone 3.25 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VI: Intrathecal Hydromorphone 3 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VII: Intrathecal Hydromorphone 2.75 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level
Group VIII: Intrathecal Hydromorphone 2.5 mcg/kgExperimental Treatment1 Intervention
Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level

Hydromorphone is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Dilaudid for:
  • Moderate to severe pain
🇨🇦
Approved in Canada as Hydromorphone for:
  • Moderate to severe pain
🇪🇺
Approved in European Union as Hydromorphone for:
  • Moderate to severe pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

In a study of 40 children undergoing posterior spinal fusion for idiopathic scoliosis, the use of intrathecal morphine resulted in lower pain scores immediately after surgery and during the first 8 hours postoperatively compared to epidural hydromorphone, indicating effective pain management.
Patients receiving intrathecal morphine were able to transition to oral analgesics sooner and had a shorter hospital stay (3.0 days vs. 3.5 days), suggesting that this method not only manages pain effectively but also promotes quicker recovery and discharge.
A retrospective comparison of intrathecal morphine and epidural hydromorphone for analgesia following posterior spinal fusion in adolescents with idiopathic scoliosis.Hong, RA., Gibbons, KM., Li, GY., et al.[2017]
In a study of 114 women undergoing elective Cesarean delivery, intrathecal hydromorphone (0.04 mg) provided similar analgesia and opioid-related side effects compared to intrathecal morphine (0.1 mg).
There were no significant differences in the frequency of complications like nausea or pruritus, total opioid consumption, or pain scores between the two groups within 24 hours post-surgery.
Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine.Beatty, NC., Arendt, KW., Niesen, AD., et al.[2022]
In a study of 1,846 patients undergoing abdominal surgery, no significant relationship was found between the dose of intrathecal hydromorphone and the level of postoperative analgesia, suggesting that higher doses do not necessarily lead to better pain relief.
However, patients receiving high doses of hydromorphone (200-300 µg) experienced a higher rate of severe opioid-related adverse events in the postanesthesia care unit, indicating a potential safety concern with increased dosing.
Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications.Charnin, JE., Weingarten, TN., Schroeder, DR., et al.[2023]

References

A retrospective comparison of intrathecal morphine and epidural hydromorphone for analgesia following posterior spinal fusion in adolescents with idiopathic scoliosis. [2017]
Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. [2022]
Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications. [2023]
Narcotic-only Epidural Infusion for Posterior Spinal Fusion Patients: A Single-Center, Retrospective Review. [2018]
Scheduled methadone reduces overall opioid requirements after pediatric posterior spinal fusion: A single center retrospective case series. [2022]
Intrathecal hydromorphone for cesarean delivery: in search of improved postoperative pain management: a case report. [2013]
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