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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of an opioid-free pain management plan with a traditional opioid-containing plan for pain relief after spine surgery in young people with idiopathic scoliosis (a type of spine curve without a known cause). The goal is to determine if managing pain without opioids can be equally effective, potentially with fewer side effects. Participants will be divided into two groups: one using opioid-free methods and the other using traditional opioid medications. The trial seeks young patients diagnosed with idiopathic scoliosis who are scheduled for a specific type of spine surgery called primary instrumented PSF. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for these treatments?

Previous studies have shown that managing pain without opioids is safe and effective for surgeries, such as those on the neck. Patients reported good pain control without needing additional opioids. Research suggests that opioid-free anesthesia can help patients recover faster and feel less sick after surgery.

Treatments that include opioids, like morphine and hydrocodone, are well-known and widely used for pain management. These treatments are common and have a known safety record, but they can sometimes cause side effects like nausea or constipation.

Both treatment options have their own benefits and risks. However, the opioid-free approach has demonstrated effectiveness with fewer side effects and faster recovery in some cases. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about opioid-free pain management for scoliosis because it aims to effectively manage pain without the use of traditional opioids, which are commonly used but come with risks of addiction and side effects. This treatment utilizes a combination of non-opioid medications like clonidine, ropivacaine, and gabapentin, along with non-medicinal therapies such as ice, aromatherapy, and music therapy, offering a holistic approach to pain relief. This protocol not only targets pain through multiple mechanisms but also encourages early mobilization, which can aid in quicker recovery. By potentially reducing reliance on opioids, this approach could revolutionize post-operative care for scoliosis patients, making it safer and more sustainable.

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

This trial will compare opioid-free and opioid-containing pain management strategies for scoliosis surgery. Research has shown that managing pain without opioids can be as effective as using them after surgery. For instance, studies have found that patients who underwent spine surgery experienced similar pain relief regardless of opioid use. One study specifically examined neck surgeries and found that non-opioid treatments provided equally effective pain control. The opioid-free approach in this trial combines various medications and therapies, such as gabapentin and physical therapy, to manage pain without opioids. This approach may offer effective pain relief with potentially fewer side effects than opioids. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Paloski, DO

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06935331

NCT06935331 | Prospective Opioid-Free AIS Fusion 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) ...

2. withpower.com withpower.com/trial/phase-4-scoliosis-4-2025-89603

Opioid-Free Pain Management for Scoliosis 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) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38553433/

Opioid-Free Analgesia is Safe and Effective in Anterior ... A multimodal OF pain management pathway following anterior cervical surgery for degenerative disease results in statistically noninferior pain control.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943020301443

Opioid-free spine surgery: a prospective study of 244 ... Opioid-free elective spine surgery, including lumbar fusions, is feasible and effective. Importantly, it can be achieved with favorable pain scores.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/19386400251333042

Comparison of an Opioid-Free Multimodal Pain Regimen ... Overall, these results suggest that an opioid-free postoperative treatment regimen has similar effectiveness in controlling a patient's pain ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT06935331

Prospective Opioid-Free AIS Fusion - Arthritis Foundation Michael Paloski and team demonstrated that a comprehensive, multimodal, OF pain management pathway following instrumented PSF for idiopathic scoliosis results ...

7. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-025-00272-9

Effectiveness and safety of opioid-free anesthesia compared ... Clinical studies suggest that patients receiving OFA experience faster recovery times, less postoperative nausea and vomiting (PONV) and ...