MedTrace Logo

NSAIDS Following Elective Lumbar Spine Fusion

NCT07743606 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2026-08-04

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Ketorolac

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

DRUG

Naproxen

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

OTHER

Standard Postoperative Pain Management

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743606 on ClinicalTrials.gov