Pain Control After Lumbar Spine Fusion

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06484192
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Naproxen 500 Mg — DRUG
    participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
  • Ketorolac — DRUG
    participants will receive Ketorolac (15 mg) immediately after surgery
  • OxyCODONE 5 mg Oral Tablet — DRUG
    participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
  • Metaxalone 800 MG — DRUG
    participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed

Study Details

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.

Key Dates

Start date
Jun 28, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Active Comparator: Group 2: Control Group
    Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery

Primary Outcome Measure

Fusion failure [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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Rothman Orthopaedic Institute· Philadelphia, PA

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