OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
NCT Number: NCT06935331
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.
Interested in participating?
Request Info10 year–20 year
All sexes
Interventional
Phase 4
Charlotte, North Carolina, 28207, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 24 hours after surgery completion
Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion
Time frame: Perioperative/Periprocedural
Morphine milliequivalents (MME) while inpatient
Time frame: Perioperative/Periprocedural
Length of hospital stay (in days/hours)
Time frame: Perioperative/Periprocedural
Presence of opioid medication prescribed at discharge
Time frame: Through study completion, an average of 1 year
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
Number of opioid refills requested or sent
Time frame: Through study completion, an average of 1 year
Instances of unplanned emergency department or clinic visits for pain
Time frame: Through study completion, an average of 1 year
Number of days missed from school
Time frame: Through study completion, an average of 1 year
Incidence of symptomatic pseudoarthrosis, confirmed either with computed tomography or during subsequent surgery
Time frame: Through study completion, an average of 1 year
Numeric Pain Rating Scale (NPRS) according to the patient.
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)
Time frame: Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) completed by patient, a single yes or no question
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
Time frame: Through study completion, an average of 1 year
Opioid medication utilization (Yes/No) after discharge
OrthoCarolina Research Institute, Inc.
Other
Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
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