Ketorolac Effects on Post-operative Pain and Lumbar Fusion

NCT06513208 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HP-00109853
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Spinal Fusion

Keywords

ketorolac; toradol; lumbar spine fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Ketorolac arm

ACTIVE COMPARATOR

Drug: Ketorolac Tromethamine

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

IV saline as placebo

Placebo Arm

Ketorolac Tromethamine DRUG

IV Ketorolac 15mg every 6 hours, x 4 doses

Ketorolac arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Medical Metrics Diagnostics, Inc: collaborator
• University of Maryland St. Joseph Medical Center: lead

Study Sites (1)

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

RECRUITING

MeSH Terms

Interventions

Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Aja Janyavula

CONTACT

410-427-5459; ajanyavula@umm.edu

Sam Rudow

CONTACT

410-427-5459; samuel.rudow@umm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)