Clinical trial NCT03278691: Ketorolac on Posterior Thoracolumbar Spinal Fusions
Official title: The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Thoracolumbar Spinal Fusions
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fusion Construct X-Ray
timeFrame: 6 months postoperatively
measure: Fusion Construct X-Ray
timeFrame: 12 months postoperatively
measure: Fusion Construct X-Ray
timeFrame: 24 months postoperatively
Secondary outcomes:
measure: Visual Analogue Scale (VAS) for pain
timeFrame: Every 8 hours x 48 hours postoperatively
measure: Length of Stay (LOS)
timeFrame: 12 months postoperatively
measure: Morphine equivalent doses
timeFrame: 12 months postoperatively
measure: Complications/Adverse events
timeFrame: 12 months postoperatively
measure: Quality of life - long term
timeFrame: 12 months and/or 24 months postoperatively
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Providence-Providence Park, Southfield
state: Michigan
Study officials:
affiliation: Michigan Spine and Brain Surgeons
name: Doris Tong, MD
role: STUDY_DIRECTOR
References:
citation: Claus CF, Lytle E, Tong D, Sigler D, Lago D, Bahoura M, Dosanjh A, Lawless M, Slavnic D, Kelkar P, Houseman C, Bono P, Richards B, Soo TM. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol. BMJ Open. 2019 Jan 21;9(1):e025855. doi: 10.1136/bmjopen-2018-025855.