Pain Control After Lumbar Spine Fusion

Phase 4

• Conditions: Postoperative Pain; Spine Fusion; NSAID (Non-Steroidal Anti-Inflammatory Drug)
• Interventions: Drug: Naproxen 500 Mg; Drug: Ketorolac; Drug: OxyCODONE 5 mg Oral Tablet; Drug: Metaxalone 800 MG

• Registration Number: NCT06484192
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study Start: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

• ≥18 years of age, ≥1-level planned lumbar spinal fusion
• Capacity to enroll
• English speaking

Exclusion Criteria

• Chronic kidney disease (preoperative creatinine ≥1.4)
• History of gastrointestinal bleed or peptic ulcer disease
• History of spinal fusion nonunion
• Non-steroidal anti-inflammatory drug allergy
• Previously diagnosed coagulopathy
• Preoperative thrombocytopenia (platelets <100,000)
• Connective tissue disease
• Operative indication due to infection, neoplasm, or trauma
• Currently pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: NSAID Group	OxyCODONE 5 mg Oral Tablet	Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Group 1: NSAID Group	Metaxalone 800 MG	Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Group 1: NSAID Group	Naproxen 500 Mg	Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Group 1: NSAID Group	Ketorolac	Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Group 2: Control Group	Metaxalone 800 MG	Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
Group 2: Control Group	OxyCODONE 5 mg Oral Tablet	Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery

Primary Outcome Measures

Name	Time	Method
Fusion failure	2 years	Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States