Pain Control After Lumbar Spine Fusion

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 4

Conditions: Postoperative Pain; NSAID (Non-Steroidal Anti-Inflammatory Drug); Spine Fusion

Treatments: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Metaxalone 800 MG; Drug: Ketorolac; Drug: Naproxen 500 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06484192

CKEP2024.0800

Details and patient eligibility

About

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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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428 participants in 2 patient groups

Group 1: NSAID Group

Active Comparator group

Description:

Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery

Treatment:

Drug: Naproxen 500 Mg

Drug: Metaxalone 800 MG

Drug: Ketorolac

Drug: OxyCODONE 5 mg Oral Tablet

Group 2: Control Group

Active Comparator group

Description:

Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery

Treatment:

Drug: Metaxalone 800 MG

Drug: OxyCODONE 5 mg Oral Tablet