NCT03278691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

6.2 years

First QC Date

August 24, 2017

Last Update Submit

April 18, 2023

Conditions

Thoracolumbar Spinal Fusions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Visual Analogue Scale (VAS) for pain

    Every 8 hours x 48 hours postoperatively

  • Length of Stay (LOS)

    12 months postoperatively

  • Morphine equivalent doses

    12 months postoperatively

  • Complications/Adverse events

    12 months postoperatively

  • Quality of life - long term

    12 months and/or 24 months postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Saline 1 ml IV Q6H

Drug: Saline

Intervention

EXPERIMENTAL

Ketorolac 15 mg (15mg/ml) IV Q6H

Drug: Ketorolac

Interventions

SalineDRUG

1 ml saline IV Q6H

Placebo
KetorolacDRUG

15 mg (15 mg/ml) IV Q6H

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Elective thoracolumbar posterior lumbar instrumented interbody fusion
  • Minimally invasive spine surgery (MIS)
  • or fewer levels
  • Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
  • Consent to study participation

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence-Providence Park, Southfield

Southfield, Michigan, 48075, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30670528DERIVED

MeSH Terms

Interventions

Sodium ChlorideKetorolac

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Doris Tong, MD

    Michigan Spine and Brain Surgeons

    STUDY DIRECTOR

Central Study Contacts

Doris Tong, MD

CONTACT

(248) 763-2380doris.tong@michiganspineandbrainsurgeons.com

Chad Claus, DO

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

September 12, 2017

Study Start

October 3, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)