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NCT Number: NCT06513208

Ketorolac Effects on Post-operative Pain and Lumbar Fusion

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

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Key information

Conditions

Lumbar Spinal Fusion

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location status: Recruiting

Location contact

Justin Tortolani, MD

PRINCIPAL_INVESTIGATOR

Sam Rudow

CONTACT

[email protected]

410-427-5459

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

IV Ketorolac 15mg every 6 hours, x 4 doses

Placebo

Drug

IV saline as placebo

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).

    Time frame: 12 months

Secondary outcomes

  1. 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).

    Time frame: 12 months

  2. 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).

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Aja Janyavula

CONTACT

[email protected]

410-427-5459

Sam Rudow

CONTACT

[email protected]

410-427-5459

Sponsors and collaborators

Lead sponsor

University of Maryland St. Joseph Medical Center

Other

Collaborators

  • Medical Metrics Diagnostics, Inc

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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