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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best dose of intrathecal hydromorphone, a pain medicine, to manage pain effectively for individuals undergoing scoliosis surgery while minimizing side effects. Participants will receive varying doses of hydromorphone to find the optimal balance between pain relief and minimal side effects. This study suits individuals undergoing spinal surgery for idiopathic scoliosis (a type of spine curvature with no known cause) through a posterior approach and who do not have chronic pain or use opioids before surgery. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for hydromorphone?

Research has shown that intrathecal hydromorphone is usually well-tolerated. Some past patients have used this treatment for pain relief without serious problems. Although specific safety data on hydromorphone is limited, studies on similar treatments, such as intrathecal morphine, suggest safety at low to moderate doses. Patients have rarely reported severe side effects, such as trouble breathing, with these doses. Since this trial is in a later phase, the treatment has already demonstrated a good safety record in earlier research stages. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using intrathecal hydromorphone for pain management in scoliosis repair because it offers a targeted approach that differs from standard options. Unlike traditional systemic opioids, which can affect the whole body and often come with significant side effects, intrathecal hydromorphone is delivered directly into the spinal fluid. This localized delivery method allows for lower doses, potentially reducing side effects while maintaining effective pain relief. Furthermore, this approach focuses pain management on the surgical area, which could enhance recovery and comfort for patients undergoing scoliosis surgery.

What evidence suggests that this trial's treatments could be effective for pain management in scoliosis repair?

Research has shown that intrathecal hydromorphone effectively manages pain after scoliosis surgery. This opioid pain medicine is delivered directly into the spinal area for strong pain relief. Studies have found that using opioids like morphine or hydromorphone in this manner helps control pain after spinal surgery. This method can be part of a multimodal approach, combining it with other pain treatments for better results. Although opioids can have side effects, this trial will test various doses of intrathecal hydromorphone to find the optimal dose that minimizes side effects while effectively managing pain. This treatment is already known to be effective for pain relief in similar conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Kathryn Handlogten, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524001652

Postoperative Analgesia After Posterior Spinal Fusion for ... IV opioids or epidural infusion are the most widely preferred postoperative pain management strategies following PSF for AIS. •. Multimodal analgesic protocols ...

2. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02525-z

Gabapentin and intrathecal morphine combination therapy ... Gabapentin and intrathecal morphine combination therapy results in decreased oral narcotic use and more consistent pain scores after posterior spinal fusion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6134554/

Postoperative pain management in patients undergoing ... In summary, IV PCA with morphine is the best established and most widely used analgesia technique for scoliosis correction surgery. However, ...

4. journals.lww.com journals.lww.com/painrpts/fulltext/2022/06000/postoperative_pain_treatment_after_spinal_fusion.8.aspx

Postoperative pain treatment after spinal fusion surgery Patients undergoing this procedure are at a high risk of acute and persistent postoperative pain, development of postoperative hyperalgesia, and possibly opioid ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05552443

A Study of Intrathecal Hydromorphone for Pediatric ... Maximum pain scores, Highest pain score reported during the first 24 hours after intrathecal opioid administration. Reported by the patient using an 11-point ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05552443

A Study of Intrathecal Hydromorphone for Pediatric ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841619/

Effectiveness and Safety of Intrathecal Morphine for Pediatric ... A low to moderate dose of ITM is a safe and effective adjunct to improve standard postoperative care without increasing the risk of respiratory depression.

8. journals.lww.com journals.lww.com/pqs/fulltext/2020/07000/methadone_based_multimodal_analgesia_provides_the.24.aspx

Methadone-based Multimodal Analgesia Provides the... Methadone-based multimodal analgesia resulted in significantly lower LOS compared with the conventional regimen. It also provided improved pain control.