Clinical trial NCT06935331: Prospective Opioid-Free AIS Fusion
Official title: Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Adolescent Idiopathic Scoliosis (AIS)
Keywords: Adolescent Idiopathic Scoliosis (AIS)
Opioid
Pain Management Pathway
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain rating on the 10-point numeric pain rating scale (NPRS)
timeFrame: 24 hours after surgery completion
Secondary outcomes:
measure: Morphine milliequivalents (MME)
timeFrame: Perioperative/Periprocedural
measure: Length of hospital stay
timeFrame: Perioperative/Periprocedural
measure: opioid medication prescribed
timeFrame: Perioperative/Periprocedural
measure: Clinic phone calls regarding uncontrolled pain
timeFrame: Through study completion, an average of 1 year
measure: Delayed opioid prescriptions sent
timeFrame: Through study completion, an average of 1 year
measure: Opioid refills requested or sent
timeFrame: Through study completion, an average of 1 year
measure: Unplanned emergency department or clinic visits for pain
timeFrame: Through study completion, an average of 1 year
measure: Days missed from school
timeFrame: Through study completion, an average of 1 year
measure: symptomatic pseudoarthrosis
timeFrame: Through study completion, an average of 1 year
measure: Numeric Pain Rating Scale (NPRS) - Patient
timeFrame: Through study completion, an average of 1 year
measure: Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian
timeFrame: Through study completion, an average of 1 year
measure: Patient Acceptable Symptom State (PASS) (patient)
timeFrame: Through study completion, an average of 1 year
measure: Patient Acceptable Symptom State (PASS) (parent/guardian)
timeFrame: Through study completion, an average of 1 year
measure: Opioid medication utilization
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Michael Paloski, DO
role: PRINCIPAL_INVESTIGATOR
References: