Prospective Opioid-Free AIS Fusion

Phase 4

Not yet recruiting

• Conditions: Adolescent Idiopathic Scoliosis (AIS)
• Interventions: Drug: Opioid-Containing; Drug: Opioid-Free/Opioid-Avoidant

• Registration Number: NCT06935331
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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.

Study Timeline

• Study First Submitted: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-Containing	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.
Opioid-Free/Opioid-Avoidant	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.

Primary Outcome Measures

Name	Time	Method
Pain rating on the 10-point numeric pain rating scale (NPRS)	24 hours after surgery completion	Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States