Ketorolac on Posterior Thoracolumbar Spinal Fusions

Ascension South East Michigan

Status and phase: Enrolling; Phase 4

Conditions: Thoracolumbar Spinal Fusions

Treatments: Drug: Ketorolac; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03278691

IRB # 1072359

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Drug: Placebo Saline 1 ml IV Q6H

Treatment:

Drug: Saline

Intervention

Experimental group

Description:

Ketorolac 15 mg (15mg/ml) IV Q6H

Treatment:

Drug: Ketorolac