Ketorolac on Posterior Thoracolumbar Spinal Fusions

The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracolumbar Spinal Fusions
• Intervention / Treatment: Drug: Saline; Drug: Ketorolac

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Recruiting
      • Providence-Providence Park, Southfield
      • Contact: Frances Williams, MBA, MPH; Phone Number: 248-849-5326; Email: Frances.Williams3@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Drug: Placebo Saline 1 ml IV Q6H	Drug: Saline; 1 ml saline IV Q6H
Experimental: Intervention; Ketorolac 15 mg (15mg/ml) IV Q6H	Drug: Ketorolac; 15 mg (15 mg/ml) IV Q6H

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Construct X-Ray	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.	6 months postoperatively
Fusion Construct X-Ray	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.	12 months postoperatively
Fusion Construct X-Ray	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.	24 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) for pain	Patient will be given the VAS on the source document in order to draw on the scale; Blinded investigators	Every 8 hours x 48 hours postoperatively
Length of Stay (LOS)	-Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR	12 months postoperatively
Morphine equivalent doses	-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	12 months postoperatively
Complications/Adverse events	-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	12 months postoperatively
Quality of life - long term	Oswestry Disability Index (ODI); We will administer validated scales (ODI); Face-to -face interview during clinic visit	12 months and/or 24 months postoperatively

Collaborators and Investigators

• Sponsor: Ascension South East Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: IRB # 1072359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes