Opioid-Free Pain Management for Scoliosis

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: OrthoCarolina Research Institute, Inc.

Disqualifiers: Non-idiopathic scoliosis, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

58 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the opioid-free treatment for pain management in scoliosis surgery?

Research shows that using a methadone-based multimodal analgesia protocol can improve pain control and reduce the need for additional opioids after major spinal surgery in adolescents with scoliosis. Additionally, preoperative education and smaller opioid prescriptions have been found to reduce opioid use and manage pain effectively after surgery. ^{1 2 3 4 5}

Is opioid-free pain management for scoliosis surgery safe?

Research on pain management for scoliosis surgery shows that while opioids are commonly used, there is a growing focus on reducing their use due to side effects. Multimodal analgesia (using different types of pain relief methods together) is being explored to improve safety and effectiveness, but more studies are needed to determine the best combinations and doses for safe opioid-free pain management. ^{2 4 6 7 8}

How is the opioid-free pain management treatment for scoliosis different from other treatments?

This treatment is unique because it focuses on avoiding opioids by using a combination of different pain management strategies, such as regional anesthesia techniques like erector spinae plane blocks, and other non-opioid medications, to effectively manage pain after scoliosis surgery. ^{4 6 8 9 10}

What is the purpose of this trial?

The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.

Research Team

Michael Paloski, DO

Principal Investigator

OrthoCarolina Research Institute, Inc.

Eligibility Criteria

This trial is for pediatric patients with idiopathic scoliosis who are undergoing a specific type of spine surgery called PSF. The study aims to include those who can follow the pain management protocol post-surgery.

Inclusion Criteria

I am between 10 and 20 years old.

I have been diagnosed with idiopathic scoliosis.

I am scheduled for a spine fusion surgery with instrumentation.

Exclusion Criteria

I am either younger than 10 or older than 20 years old at the time of my surgery.

My scoliosis is caused by a condition like muscle or nerve disorders.

I am having a spinal surgery that does not involve fusion, like growing rods.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo instrumented posterior spinal fusion (PSF) and are managed post-operatively with either an opioid-free or opioid-containing pain regimen

1 week

Inpatient stay

Follow-up

Participants are monitored for safety, effectiveness, and pain management outcomes after discharge

1 year

Regular follow-up visits and phone calls

Treatment Details

Interventions

• Opioid-Containing
• Opioid-Free/Opioid-Avoidant

Trial Overview The study compares two pain management protocols after spine surgery: one group will receive an opioid-free approach, while the other will have traditional treatment that includes opioids.

Participant Groups

Group I: Opioid-Free/Opioid-Avoidant Experimental Treatment 1 Intervention

Managed post-operatively with an opioid-free pain regimen which will include: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound. Gabapentin PO 300 mg TID x 30 days. Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours. Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs. Acetaminophen PO dosed per body weight and discharged home with PO tabs. Diazepam PO dosed per body weight during stay and discharged home with PO tabs. Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT.

Group II: Opioid-Containing Active Control 1 Intervention

Managed post-operatively with a traditional opioid containing pain regimen including: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound. Post-operative morphine IV for breakthrough pain. Oral narcotic (hydrocodone/acetaminophen). Gabapentin PO 300 mg TID x 30 days. Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours. Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs. Acetaminophen PO dosed per body weight and discharged home with PO tabs. Diazepam PO dosed per body weight during stay and discharged home with PO tabs. Non-medicinal therapy: Ice, Early mobilization and PT.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Findings from Research

A rapid recovery pathway (RRP) for adolescent idiopathic scoliosis patients undergoing spinal fusion surgery significantly reduced opioid consumption in the first two postoperative days, with a mean difference of 61.6 morphine milligram equivalents (MME) compared to traditional methods.

Patients in the RRP group also experienced a shorter hospital stay, averaging 2.5 days compared to 4.0 days for those receiving epidural catheter analgesia, indicating that the RRP can effectively accelerate recovery without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. Colón, LF., Powell, C., Wilson, A., et al.[2023]

The implementation of a methadone-based multimodal analgesia protocol in 122 idiopathic scoliosis patients significantly reduced the length of hospital stay from a median of 3 days to 2 days compared to the conventional pain management regimen.

Patients on the new protocol experienced lower total opioid consumption and improved pain control by postoperative day 2, along with a quicker return to bowel function, indicating enhanced recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methadone-based Multimodal Analgesia Provides the Best-in-class Acute Surgical Pain Control and Functional Outcomes With Lower Opioid Use Following Major Posterior Fusion Surgery in Adolescents With Idiopathic Scoliosis. Ye, J., Myung, K., Packiasabapathy, S., et al.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. [2023]

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

Preoperative Patient Education and Smaller Prescription Quantity Reduce Opioid Use After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: Results of a Prospective Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Extension of Surgery Predicts Acute Postoperative Pain, While Persistent Postoperative Pain Is Related to the Spinal Pathology in Adolescents Undergoing Posterior Spinal Fusion. [2022]

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

Methadone-based Multimodal Analgesia Provides the Best-in-class Acute Surgical Pain Control and Functional Outcomes With Lower Opioid Use Following Major Posterior Fusion Surgery in Adolescents With Idiopathic Scoliosis. [2022]

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

Intrathecal Morphine Use in Adolescent Idiopathic Scoliosis Surgery is Associated with Decreased Opioid Use and Decreased Length of Stay. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. [2022]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. [2021]

10. France pubmed.ncbi.nlm.nih.gov

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