NCT06484192

Pain Control After Lumbar Spine Fusion

Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.

Conditions

• Spine Fusion
• NSAID (Non-Steroidal Anti-Inflammatory Drug)
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Naproxen 500 Mg	participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
DRUG	Ketorolac	participants will receive Ketorolac (15 mg) immediately after surgery
DRUG	OxyCODONE 5 mg Oral Tablet	participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
DRUG	Metaxalone 800 MG	participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed

Timeline

• Start date: 2024-06-28
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study