Adolescent Idiopathic Scoliosis (AIS)
Conditions
Keywords
Adolescent Idiopathic Scoliosis (AIS), Opioid, Pain Management Pathway
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.
Interventions
DRUGOpioid-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
DRUGOpioid-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
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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) |
| 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 |
| Opioid medication utilization | Through study completion, an average of 1 year | Opioid medication utilization (Yes/No) after discharge |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Paloski, DO
OrthoCarolina Research Institute, Inc.
Outcome results
None listed