Prospective Opioid-Free AIS Fusion

NCT06935331 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 9209
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Adolescent Idiopathic Scoliosis (AIS); Opioid; Pain Management Pathway

Outcome Measures

Primary Outcomes (1)

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

  Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion

  24 hours after surgery completion

Secondary Outcomes (14)

• Morphine milliequivalents (MME)

  Perioperative/Periprocedural

• Length of hospital stay

  Perioperative/Periprocedural

• opioid medication prescribed

  Perioperative/Periprocedural

• Clinic phone calls regarding uncontrolled pain

  Through study completion, an average of 1 year

• Delayed opioid prescriptions sent

  Through study completion, an average of 1 year

Study Arms (2)

Opioid-Free/Opioid-Avoidant

EXPERIMENTAL

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-Free/Opioid-Avoidant

Opioid-Containing

ACTIVE COMPARATOR

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.

Drug: Opioid-Containing

Interventions

Opioid-Free/Opioid-Avoidant DRUG

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

Opioid-Free/Opioid-Avoidant

Opioid-Containing DRUG

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

Opioid-Containing

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients (10-20 years of age at the time of surgery)
• Diagnosis of idiopathic scoliosis
• Undergoing primary instrumented PSF

You may not qualify if:

• 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Study Officials

• Michael Paloski, DO

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Michalek, BS

CONTACT

7043233698; caleb.michalek@orthocarolina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 20, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)