Pain Control After Lumbar Spine Fusion

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain; Spine Fusion; NSAID (Non-Steroidal Anti-Inflammatory Drug)
• Intervention / Treatment: Drug: Naproxen 500 Mg; Drug: Ketorolac; Drug: OxyCODONE 5 mg Oral Tablet; Drug: Metaxalone 800 MG

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: NSAID Group; Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery	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
Active Comparator: Group 2: Control Group; Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion failure	Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays	2 years

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Neuromuscular Agents; Gout Suppressants; Ketorolac; Oxycodone; Naproxen; Metaxalone
• Other Study ID Numbers: CKEP2024.0800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes