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Enrolling by Invitation

NCT Number: NCT07743606

NSAIDS Following Elective Lumbar Spine Fusion

This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge.

The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.

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Key information

Conditions

NSAID (Non-Steroidal Anti-Inflammatory Drug) Ketorolac Lumbar Spine Fusion Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.

Naproxen

Drug

Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.

Standard Postoperative Pain Management

Other

Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.

Primary outcomes

  1. Revision surgery for symptomatic lumbar spinal fusion nonunion

    Time frame: Up to 2 years after surgery

    The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings.

Secondary outcomes

  1. Radiographic lumbar fusion status

    Time frame: 6 months, 1 year, and 2 years after surgery

    The proportion of participants with radiographic evidence of nonunion (pseudarthrosis) based on standard radiographs and/or computed tomography (CT), as determined by the treating spine surgeon.

  2. Inpatient opioid consumption

    Time frame: During the index hospitalization (up to approximately 3 days)

    Total opioid consumption during hospitalization, converted to morphine milligram equivalents (MME).

  3. Postoperative outpatient opioid consumption

    Time frame: 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery

    Daily opioid use, reported as morphine milligram equivalents (MME), at routine postoperative follow-up visits.

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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