Intrathecal Hydromorphone for Pain Management in Scoliosis Repair

Overseen By Handlogten

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Chronic pain, Spinal abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 3 5 6}

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

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

Group I: Intrathecal Hydromorphone 5 mcg/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications. Charnin, JE., Weingarten, TN., Schroeder, DR., et al.[2023]

In a study of 56 children undergoing posterior spinal fusion for idiopathic scoliosis, hydromorphone patient-controlled epidural analgesia was found to be a safe and effective alternative for postoperative pain management, with no respiratory or neurological adverse events reported.

The use of hydromorphone resulted in manageable pain scores and a mean hospital stay of approximately 4 days, suggesting it provides adequate analgesia while maintaining a favorable side-effect profile compared to traditional IV-PCA methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narcotic-only Epidural Infusion for Posterior Spinal Fusion Patients: A Single-Center, Retrospective Review. Hong, R., Gauger, V., Caird, MS., et al.[2018]

A protocol using scheduled postoperative methadone significantly reduced opioid usage by 45% compared to a patient-controlled analgesia (PCA) strategy in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis, with 22 patients in the methadone group consuming only 0.18 mg/kg of hydromorphone equivalents.

Both pain and sedation scores were similar across all groups, indicating that the reduction in opioid use did not compromise pain management effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduled methadone reduces overall opioid requirements after pediatric posterior spinal fusion: A single center retrospective case series. Mok, V., Sweetman, S., Hernandez, B., et al.[2022]

Intrathecal hydromorphone provided superior pain relief with fewer side effects compared to intrathecal morphine in a 22-year-old woman undergoing a cesarean delivery, suggesting it may be a better alternative for patients with opioid allergies.

This case report highlights the potential of intrathecal hydromorphone as a safe and effective option for postoperative pain management, warranting further research to confirm its benefits over traditional opioids like morphine and fentanyl.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal hydromorphone for cesarean delivery: in search of improved postoperative pain management: a case report. Rauch, E.[2013]

References

1. France pubmed.ncbi.nlm.nih.gov

A retrospective comparison of intrathecal morphine and epidural hydromorphone for analgesia following posterior spinal fusion in adolescents with idiopathic scoliosis. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Narcotic-only Epidural Infusion for Posterior Spinal Fusion Patients: A Single-Center, Retrospective Review. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Scheduled methadone reduces overall opioid requirements after pediatric posterior spinal fusion: A single center retrospective case series. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Intrathecal hydromorphone for cesarean delivery: in search of improved postoperative pain management: a case report. [2013]