Ketorolac Effects on Post-operative Pain and Lumbar Fusion
Phase 4
Not yet recruiting
- Conditions
- Spinal Fusion
- Interventions
- Drug: Placebo
- Registration Number
- NCT06513208
- Lead Sponsor
- University of Maryland St. Joseph Medical Center
- 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.
Primary objective
- To demonstrate Ketorolac results in decreased postoperative opioid use following posterior spinal fusions during the first 48 hours.
Secondary objectives
* To demonstrate that the use of Ketorolac does not decrease spinal fusion in one or two level instrumented spinal fusions.
* To demonstrate the use of Ketorolac decreases the average length of stay following spinal fusions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- 18-85 years of age
- Elective posterior lumbar instrumented fusion
- One- or two-level fusion
- Consent to participate in study, and willing to adhere to study follow up
Exclusion Criteria
-
-
- Under age of 18 y/o or over age 85.
-
- History of renal failure, dialysis or creatinine over 1.50mg/dl
- Active smoker or history of within the last 6 months
- Revision surgery
- Auto/worker compensation
- Active cancer or history of chemotherapy in last 6 months
- Active narcotic use within 3 months of surgery date.
- Infection at operative levels
- Any allergies to NSAIDs or Opioids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm Placebo - Ketorolac arm Ketorolac Tromethamine -
- Primary Outcome Measures
Name Time Method 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. 6 months
- Secondary Outcome Measures
Name Time Method 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. 6 months Ketorolac use does not decrease spinal fusion rates in one to two level fusion. Fusion failure is measured by > than 2 degrees motion on standardized flexion/extension x-rays when compared to pre-op imaging analyzed by spinecamp software at the 6 months. 6 months'