Pain Control After Lumbar Spine Fusion

Phase 4Enrolling By InvitationNCT06484192

Rothman Institute Orthopaedics428 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

428

Conditions

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

Interventions

Naproxen 500 MgDRUG

participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed

KetorolacDRUG

participants will receive Ketorolac (15 mg) immediately after surgery

OxyCODONE 5 mg Oral TabletDRUG

participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Fusion failure

Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays

Time frame: 2 years

Data from ClinicalTrials.gov

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