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Pain Control After Lumbar Spine Fusion

NCT06484192 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

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

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

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
2024-06-28
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06484192 on ClinicalTrials.gov