Pain Control After Lumbar Spine Fusion

Last updated: June 26, 2024
Sponsor: Rothman Institute Orthopaedics
Overall Status: Active - Enrolling

Phase

4

Condition

Pain

Chronic Pain

Acute Pain

Treatment

OxyCODONE 5 mg Oral Tablet

Metaxalone 800 MG

Ketorolac

Clinical Study ID

NCT06484192
CKEP2024.0800
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years of age, ≥1-level planned lumbar spinal fusion

  • Capacity to enroll

  • English speaking

Exclusion

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

Total Participants: 428
Treatment Group(s): 4
Primary Treatment: OxyCODONE 5 mg Oral Tablet
Phase: 4
Study Start date:
June 28, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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