Using low-dose ketorolac for pain management after spinal fusion surgery
The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
This study is testing if giving low-dose ketorolac for pain relief right after spinal fusion surgery helps patients feel better without affecting their recovery compared to standard pain treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Southfield, Michigan) |
| Trial ID | NCT03278691 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of low-dose ketorolac for pain relief in patients undergoing elective thoracolumbar spinal fusion surgery. It aims to determine if administering ketorolac within the first 48 hours post-surgery provides sufficient analgesia without negatively impacting spinal fusion rates compared to traditional pain management methods that do not include NSAIDs. The study will involve patients who meet specific eligibility criteria, including age and surgical requirements, and will compare outcomes between those receiving ketorolac and those receiving saline as a control.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective minimally invasive thoracolumbar spinal fusion surgery.
Not a fit: Patients with a history of certain medical conditions, previous surgeries at the operative levels, or those who are active smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance pain management for patients undergoing spinal fusion while maintaining optimal healing outcomes.
How similar studies have performed: Previous studies have shown varying results with NSAIDs in post-operative pain management, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Southfield, Michigan
- Providence-Providence Park, Southfield — Southfield, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Doris Tong, MD
- Email: doris.tong@michiganspineandbrainsurgeons.com
- Phone: (248) 763-2380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.