Thoracolumbar Spinal Fusions
Conditions
Brief summary
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
Interventions
DRUGSaline
1 ml saline IV Q6H
DRUGKetorolac
15 mg (15 mg/ml) IV Q6H
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years of age * Elective thoracolumbar posterior lumbar instrumented interbody fusion * Minimally invasive spine surgery (MIS) * 3 or fewer levels * Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less) * Consent to study participation
Exclusion criteria
* Active tobacco smoker or history of tobacco smoking in the past 6 weeks * Previous history of surgery at operative level(s) * History of chronic inflammatory/rheumatological condition * History of systemic steroid use in the past 3 months * Auto/Workers' compensation patients * Traumatic pathology at the operative levels * Infection at the operative levels * Tumor at the operative levels * Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants * Patients on chemotherapeutic agents in the last 6 months * Patients who has a history of allergy to Ketorolac * Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance * Patients with current creatinine \> 1.5mg/dl * Patients with history of coagulopathy * Patients with history of hepatic impairment * Patients with uncontrolled cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Construct X-Ray | 6 months postoperatively | Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for pain | Every 8 hours x 48 hours postoperatively | * Patient will be given the VAS on the source document in order to draw on the scale * Blinded investigators |
| Length of Stay (LOS) | 12 months postoperatively | -Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR |
| Morphine equivalent doses | 12 months postoperatively | -Non-study narcotics taken by patients on the floor are converted to morphine equivalent doses * Morphine equivalent doses are compared between the two groups daily for the first 48h * Data extracted from hospital EMR on discharge |
| Complications/Adverse events | 12 months postoperatively | -Ketorolac-related short term in-hospital complications: GI ulceration and bleeding, GI perforation, PO bleeding, acute renal failure, anaphylactic/anaphylactoid reactions, liver failure * Collected by investigators daily during round * Document on the source document |
| Quality of life - long term | 12 months and/or 24 months postoperatively | Oswestry Disability Index (ODI) * We will administer validated scales (ODI) * Face-to -face interview during clinic visit |
Countries
United States
Contacts
Primary ContactDoris Tong, MD
Backup ContactChad Claus, DO
Outcome results
None listed