Prospective Opioid-Free AIS Fusion

NCT ID: NCT06935331

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

Opioids are the most common controlled medication used medically and non-medically by adolescents in the United States. Opioid prescribing practices are inextricably linked with the ongoing public health crisis of opioid misuse in the peri-adolescent population. However, the immediate postoperative period following instrumented posterior spinal fusion (PSF) for idiopathic scoliosis represents a difficult challenge for patients and surgeons alike - particularly with regard to pain control. Opioid medications are commonly used to manage early postoperative pain in these patients, though are associated with potentially deleterious effects and remain at the center of a national health crisis. In particular for peri-adolescent patients, opioids are known to disrupt central nervous system maturation, which may lead to long-term behavioral dysfunction, including increased vulnerability to addiction in adulthood. On the other hand, it is well-recognized that inadequate pain control is associated with atelectasis, delayed mobilization, protracted hospitalization, and increased complication rates following posterior instrumented PSF for idiopathic scoliosis. Consequently, there is a rising, unmet need to develop postoperative recovery pathways for this population, aimed at efficient and safe pain management that minimizes or eliminates opioids while ensuring a positive postoperative experience for the patient.

Previous studies in adult and pediatric patients have compared traditional opioid-based pain regimens to opioid-sparing regimens in the perioperative period, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, reliance on opioids for early postoperative analgesia, and/or lack of patient-reported outcomes. While there are growing efforts to investigate and adopt opioid-free (OF) protocols in adult orthopaedic patients, such protocols have yet to be thoroughly evaluated in the pediatric population. A prior study approved and completed (Protocol# PED032) by Dr. Michael Paloski and team demonstrated that a comprehensive, multimodal, OF pain management pathway following instrumented PSF for idiopathic scoliosis results in equivalent length of stay and fewer opioids prescribed at discharge compared with a traditional opioid-containing (OC) pathway. To our knowledge, this was the first study to show that completely OF postoperative pain management is possible in this population. Additional studies, including the study proposed here, are necessary to evaluate patient-reported outcomes in this population when OF pain management is utilized and to delineate patient-specific and procedure-specific details that may predict success with an OF regimen.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opioid-Free/Opioid-Avoidant

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 Type: EXPERIMENTAL

Opioid-Free/Opioid-Avoidant

Intervention Type: DRUG

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

Opioid-Containing

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.

Group Type: ACTIVE_COMPARATOR

Opioid-Containing

Intervention Type: DRUG

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

Interventions

Opioid-Free/Opioid-Avoidant

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

Intervention Type: DRUG

Opioid-Containing

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pediatric patients (10-20 years of age at the time of surgery)
• Diagnosis of idiopathic scoliosis
• Undergoing primary instrumented PSF

Exclusion Criteria

• Age <10 years or >20 years at time of surgery
• Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis
• Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Paloski, DO

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute, Inc.

Locations

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Countries

United States

Central Contacts

Caleb Michalek, BS

Role: CONTACT

caleb.michalek@orthocarolina.com

7043233698

Facility Contacts

Caleb Michalek, BS

Role: primary

caleb.michalek@orthocarolina.com

704-323-3698

Other Identifiers

9209

Identifier Type: -

Identifier Source: org_study_id