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ENROLLING BY INVITATION
NCT06484192
PHASE4

Pain Control After Lumbar Spine Fusion

Sponsor: Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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.

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

2024-06-28

Completion Date

2025-06-30

Last Updated

2024-07-03

Healthy Volunteers

Yes

Interventions

DRUG

Naproxen 500 Mg

participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed

DRUG

Ketorolac

participants will receive Ketorolac (15 mg) immediately after surgery

DRUG

OxyCODONE 5 mg Oral Tablet

participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed

DRUG

Metaxalone 800 MG

participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States