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Prospective Opioid-Free AIS Fusion

NCT06935331 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Adolescent Idiopathic Scoliosis (AIS)

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 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

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 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 & Collaborators

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Michael Paloski, DO · OrthoCarolina Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935331 on ClinicalTrials.gov