Ketorolac Effects on Post-operative Pain and Lumbar Fusion

University of Maryland St. Joseph Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Lumbar Spinal Fusion

Treatments: Drug: Ketorolac Tromethamine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06513208

HP-00109853

Details and patient eligibility

About

A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-85 years old (inclusive)
• Elective posterior lumbar instrumented fusion
• One or two level fusion
• Consent to participate in study and willing to adhere to study follow up
• English proficiency

Exclusion criteria

• < 18 or > 85 years old
• History of renal failure, dialysis, or creatinine over 1.50 mg/dl
• Active or recent smoker (active within past 6 months)
• Revision surgery
• Auto/worker compensation
• Active cancer or history of chemotherapy in past 6 months
• Active narcotic use within 3 months of surgery date
• Infection at operative levels
• Any allergies to NSAIDs or Opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Ketorolac arm

Active Comparator group

Treatment:

Drug: Ketorolac Tromethamine

Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo