Ketorolac Effects on Post-operative Pain and Lumbar Fusion

Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial

A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Fusion
• Intervention / Treatment: Drug: Placebo; Drug: Ketorolac Tromethamine

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aja Janyavula; Phone Number: 410-427-5459; Email: ajanyavula@umm.edu
• Study Contact Backup: Name: Sam Rudow; Phone Number: 410-427-5459; Email: samuel.rudow@umm.edu

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Recruiting
      • University of Maryland St. Joseph Medical Center
      • Contact: Sam Rudow; Phone Number: 410-427-5459; Email: samuel.rudow@umm.edu
      • Principal Investigator: Justin Tortolani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-85 years old (inclusive)
• Elective posterior lumbar instrumented fusion
• One or two level fusion
• Consent to participate in study and willing to adhere to study follow up
• English proficiency

Exclusion Criteria:

• < 18 or > 85 years old
• History of renal failure, dialysis, or creatinine over 1.50 mg/dl
• Active or recent smoker (active within past 6 months)
• Revision surgery
• Auto/worker compensation
• Active cancer or history of chemotherapy in past 6 months
• Active narcotic use within 3 months of surgery date
• Infection at operative levels
• Any allergies to NSAIDs or Opioids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	Drug: Placebo; IV saline as placebo
Active Comparator: Ketorolac arm	Drug: Ketorolac Tromethamine; IV Ketorolac 15mg every 6 hours, x 4 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).	12 months
Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).	12 months

Collaborators and Investigators

• Sponsor: University of Maryland St. Joseph Medical Center
• Collaborators: Medical Metrics Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ketorolac; toradol; lumbar spine fusion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indomethacin; Indoles; Ketorolac Tromethamine
• Other Study ID Numbers: HP-00109853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes