Intrathecal Hydromorphone for Pain Management in Scoliosis Repair

Recruiting in Palo Alto (17 mi)

Overseen by Kathryn Handlogten, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Chronic pain, Spinal abnormalities, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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.

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}

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.

Trial 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 (Opioid Analgesic)

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 Canada for the following indications:

Approved in Canada as Hydromorphone for:

• Moderate to severe pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3427

Patients Recruited

3,221,000+

Findings from Research

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]

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]

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]

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]

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]

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]