By InvitationPhase 4

Prospective Opioid-Free AIS Fusion

United States58 participantsStarted 2025-10-14

Plain-language 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.

Who can participate

Age range10 Years – 20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain rating on the 10-point numeric pain rating scale (NPRS)

Timeframe: 24 hours after surgery completion

Trial details

NCT IDNCT06935331

SponsorOrthoCarolina Research Institute, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis (AIS) trials