Status:
NOT_YET_RECRUITING
Prospective Opioid-Free AIS Fusion
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Conditions:
Adolescent Idiopathic Scoliosis (AIS)
Eligibility:
All Genders
10-20 years
Phase:
PHASE4
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 instr...
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 hea...
Eligibility Criteria
Inclusion
- Pediatric patients (10-20 years of age at the time of surgery)
- Diagnosis of idiopathic scoliosis
- Undergoing primary instrumented PSF
Exclusion
- 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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06935331
Start Date
August 15 2025
End Date
December 31 2027
Last Update
August 3 2025
Active Locations (1)
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1
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207