NSAIDS Following Elective Lumbar Spine Fusion

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT07743606
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

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

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Jul 8, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Active Comparator: NSAID Group
    Participants will receive the institution's standard postoperative pain management regimen plus postoperative NSAID therapy consisting of intravenous ketorolac (15 mg every 6 hours for up to 48 hours while hospitalized) followed by oral naproxen (500 mg twice daily for 7 days after hospital discharge). If a participant is discharged before completing 48 hours of ketorolac therapy, no additional inpatient doses will be administered.
  • Active Comparator: Control Group
    Participants will receive the institution's standard postoperative pain management regimen without postoperative NSAIDs. No placebo will be administered.

Primary Outcome Measure

Revision surgery for symptomatic lumbar spinal fusion nonunion [ Time Frame: Up to 2 years after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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Rothman Orthopaedic Institute· Philadelphia, PA

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