Ketorolac on Posterior Thoracolumbar Spinal Fusions

• Sponsor: Ascension South East Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03278691
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.9
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracolumbar Spinal Fusions	Drug: Saline; Drug: Ketorolac	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
• Actual Study Start Date: Oct 3, 2017
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fusion Construct X-Ray [6 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.

2. Fusion Construct X-Ray [12 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

1. 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

2. Length of Stay (LOS) [12 months postoperatively]

   -Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR

3. Quality of life - long term [12 months postoperatively]

   Short Form (SF) 12 We will administer validated scales, Short form (SF)12 Face-to -face interview during clinic visit

4. 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

5. 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

6. Quality of life - long term [12 months postoperatively]

   Oswestry Disability Index (ODI) We will administer validated scales (ODI) Face-to -face interview during clinic visit

7. Quality of life - long term [12 months postoperatively]

   We will administer validated scales, Visual Analog Scale (VAS) Face-to -face interview during clinic visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence-Providence Park, Southfield	Southfield	Michigan	United States	48075

Sponsors and Collaborators

• Ascension South East Michigan

Investigators

• Principal Investigator: Chad Claus, DO, Providence-Providence Park Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ascension South East Michigan
• ClinicalTrials.gov Identifier: NCT03278691
• Other Study ID Numbers: IRB # 1072359
• First Posted: Sep 12, 2017
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Ketorolac

Study Results

No Results Posted as of Nov 24, 2021