Ketorolac, Lumbar Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug), Postoperative Pain
Conditions
Brief summary
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge. The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
Interventions
DRUGKetorolac
Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.
DRUGNaproxen
Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.
Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Surgeon will be blinded to which group each patient is in. Surgeons will make the determinations regarding clinical course, need for further workup, and assessment of fusion status on radiographs and advanced imaging. Patients will not be notified explicitly unless they ask, and they will not receive any form of placebo medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years of age, ≥1-level planned lumbar spinal fusion * Capacity to enroll * English speaking
Exclusion criteria
* Chronic kidney disease (preoperative creatinine ≥1.4) * History of gastrointestinal bleed or peptic ulcer disease * History of spinal fusion nonunion * Non-steroidal anti-inflammatory drug allergy * Previously diagnosed coagulopathy * Preoperative thrombocytopenia (platelets \<100,000) * Connective tissue disease * Operative indication due to infection, neoplasm, or trauma * Currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision surgery for symptomatic lumbar spinal fusion nonunion | Up to 2 years after surgery | The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic lumbar fusion status | 6 months, 1 year, and 2 years after surgery | The proportion of participants with radiographic evidence of nonunion (pseudarthrosis) based on standard radiographs and/or computed tomography (CT), as determined by the treating spine surgeon. |
| Inpatient opioid consumption | During the index hospitalization (up to approximately 3 days) | Total opioid consumption during hospitalization, converted to morphine milligram equivalents (MME). |
| Postoperative outpatient opioid consumption | 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery | Daily opioid use, reported as morphine milligram equivalents (MME), at routine postoperative follow-up visits. |
Countries
United States
Outcome results
None listed