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ENROLLING BY INVITATION
NCT07743606
PHASE3

NSAIDS Following Elective Lumbar Spine Fusion

Sponsor: Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

428

Start Date

2024-07-08

Completion Date

2028-12-31

Last Updated

2026-08-04

Healthy Volunteers

Yes

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.

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States