Recruiting NCT06513208
Ketorolac Effects on Post-operative Pain and Lumbar Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketorolac Tromethamine, Placebo.
- Who it may be relevant to
- Registry conditions: Lumbar Spinal Fusion. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
Overview
A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.
Interventions
- Drug Ketorolac Tromethamine
IV Ketorolac 15mg every 6 hours, x 4 doses - Drug Placebo
IV saline as placebo
Primary outcome measures
- 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 outcome measures (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). [Time frame: 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). [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Maryland St. Joseph Medical Center — Towson
Identifiers
NCT: NCT06513208 · HP-00109853