Prospective Opioid-Free AIS Fusion

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

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"

Trial Locations (1)

28207

OrthoCarolina Research Institute, Charlotte

All Listed Sponsors
lead

OrthoCarolina Research Institute, Inc.

OTHER