Prospective Opioid-Free AIS Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid-Free/Opioid-Avoidant, Opioid-Containing.
- Who it may be relevant to
- Registry conditions: Adolescent Idiopathic Scoliosis (AIS). Basic parameters: 10 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Pain rating on the 10-point numeric pain rating scale (NPRS) [Time frame: 24 hours after surgery completion]
Secondary outcome measures (12)
- Morphine milliequivalents (MME) [Time frame: Perioperative/Periprocedural]
- Length of hospital stay [Time frame: Perioperative/Periprocedural]
- opioid medication prescribed [Time frame: Perioperative/Periprocedural]
- Clinic phone calls regarding uncontrolled pain [Time frame: Through study completion, an average of 1 year]
- Delayed opioid prescriptions sent [Time frame: Through study completion, an average of 1 year]
- Opioid refills requested or sent [Time frame: Through study completion, an average of 1 year]
- Unplanned emergency department or clinic visits for pain [Time frame: Through study completion, an average of 1 year]
- Days missed from school [Time frame: Through study completion, an average of 1 year]
- symptomatic pseudoarthrosis [Time frame: Through study completion, an average of 1 year]
- Numeric Pain Rating Scale (NPRS) - Patient [Time frame: Through study completion, an average of 1 year]
- Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian [Time frame: Through study completion, an average of 1 year]
- Patient Acceptable Symptom State (PASS) (patient) [Time frame: Through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OrthoCarolina Research Institute — Charlotte
Identifiers
NCT: NCT06935331 · 9209