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Enrolling by Invitation

NCT Number: 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) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.

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Key information

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid-Free/Opioid-Avoidant

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

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

Primary outcomes

  1. Pain rating on the 10-point numeric pain rating scale (NPRS)

    Time frame: 24 hours after surgery completion

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

Secondary outcomes

  1. Morphine milliequivalents (MME)

    Time frame: Perioperative/Periprocedural

    Morphine milliequivalents (MME) while inpatient

  2. Length of hospital stay

    Time frame: Perioperative/Periprocedural

    Length of hospital stay (in days/hours)

  3. opioid medication prescribed

    Time frame: Perioperative/Periprocedural

    Presence of opioid medication prescribed at discharge

  4. Clinic phone calls regarding uncontrolled pain

    Time frame: Through study completion, an average of 1 year

    Clinic phone calls regarding uncontrolled pain

  5. Delayed opioid prescriptions sent

    Time frame: Through study completion, an average of 1 year

    Delayed opioid prescriptions sent

  6. Opioid refills requested or sent

    Time frame: Through study completion, an average of 1 year

    Number of opioid refills requested or sent

  7. Unplanned emergency department or clinic visits for pain

    Time frame: Through study completion, an average of 1 year

    Instances of unplanned emergency department or clinic visits for pain

  8. Days missed from school

    Time frame: Through study completion, an average of 1 year

    Number of days missed from school

  9. symptomatic pseudoarthrosis

    Time frame: Through study completion, an average of 1 year

    Incidence of symptomatic pseudoarthrosis, confirmed either with computed tomography or during subsequent surgery

  10. Numeric Pain Rating Scale (NPRS) - Patient

    Time frame: Through study completion, an average of 1 year

    Numeric Pain Rating Scale (NPRS) according to the patient.

  11. Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian

    Time frame: 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)

  12. Patient Acceptable Symptom State (PASS) (patient)

    Time frame: Through study completion, an average of 1 year

    Patient Acceptable Symptom State (PASS) completed by patient, a single yes or no question

  13. Patient Acceptable Symptom State (PASS) (parent/guardian)

    Time frame: Through study completion, an average of 1 year

    Patient Acceptable Symptom State (PASS) according to the parent/guardian, a single yes or no question

  14. Opioid medication utilization

    Time frame: Through study completion, an average of 1 year

    Opioid medication utilization (Yes/No) after discharge

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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