Prospective Opioid-Free AIS Fusion

Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic 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) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adolescent Idiopathic Scoliosis (AIS)
• Intervention / Treatment: Drug: Opioid-Free/Opioid-Avoidant; Drug: Opioid-Containing

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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain rating on the 10-point numeric pain rating scale (NPRS)	Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion	24 hours after surgery completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine milliequivalents (MME)	Morphine milliequivalents (MME) while inpatient	Perioperative/Periprocedural
Length of hospital stay	Length of hospital stay (in days/hours)	Perioperative/Periprocedural
opioid medication prescribed	Presence of opioid medication prescribed at discharge	Perioperative/Periprocedural
Clinic phone calls regarding uncontrolled pain	Clinic phone calls regarding uncontrolled pain	Through study completion, an average of 1 year
Delayed opioid prescriptions sent	Delayed opioid prescriptions sent	Through study completion, an average of 1 year
Opioid refills requested or sent	Number of opioid refills requested or sent	Through study completion, an average of 1 year
Unplanned emergency department or clinic visits for pain	Instances of unplanned emergency department or clinic visits for pain	Through study completion, an average of 1 year
Days missed from school	Number of days missed from school	Through study completion, an average of 1 year
symptomatic pseudoarthrosis	Incidence of symptomatic pseudoarthrosis, confirmed either with computed tomography or during subsequent surgery	Through study completion, an average of 1 year
Numeric Pain Rating Scale (NPRS) - Patient	Numeric Pain Rating Scale (NPRS) according to the patient.	Through study completion, an average of 1 year
Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian	Perceived Numeric Pain Rating Scale (NPRS) according to Parent/Guardian (0-10 with 10 being the worst)	Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (patient)	Patient Acceptable Symptom State (PASS) completed by patient, a single yes or no question	Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (parent/guardian)	Patient Acceptable Symptom State (PASS) according to the parent/guardian, a single yes or no question	Through study completion, an average of 1 year
Opioid medication utilization	Opioid medication utilization (Yes/No) after discharge	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Michael Paloski, DO, OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Opioid; Adolescent Idiopathic Scoliosis (AIS); Pain Management Pathway
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 9209 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No