Lumbar Spinal Fusion
Conditions
Keywords
ketorolac, toradol, lumbar spine fusion
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.
Interventions
DRUGKetorolac Tromethamine
IV Ketorolac 15mg every 6 hours, x 4 doses
DRUGPlacebo
IV saline as placebo
Sponsors
Medical Metrics Diagnostics, Inc
University of Maryland St. Joseph Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Contacts
Primary ContactAja Janyavula
Backup ContactSam Rudow
Outcome results
None listed