Ketorolac on Posterior Thoracolumbar Spinal Fusions

Phase 4

Recruiting

• Conditions: Thoracolumbar Spinal Fusions
• Interventions: Drug: Ketorolac; Drug: Saline

• Registration Number: NCT03278691
• Lead Sponsor: Ascension South East Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2017-10-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ketorolac	Ketorolac 15 mg (15mg/ml) IV Q6H
Placebo	Saline	Drug: Placebo Saline 1 ml IV Q6H

Primary Outcome Measures

Name	Time	Method
Fusion Construct X-Ray	24 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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Providence-Providence Park, Southfield; 🇺🇸 Southfield, Michigan, United States