A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.

Completed · Phase 4 · Has a placebo group

Conditions studied: Lumbar Spine Degeneration

In brief

The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.

Key facts

Study ID

NCT04644796

Run by

University of Missouri-Columbia

People needed

34

Starts

2021-02-10

Expected to finish

2022-06-13

Last updated by the study team

2023-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing isolated lumbar spine procedures using a posterior approach.
• Surgical spine procedures include:
• Single-level lumbar spine surgeries with or without fusion
• Multi-level lumbar spine surgeries with or without fusion

You may not qualify if…

• Procedures involving intrathecal space
• Patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine).
• Acute lumbar trauma that requires immediate spine stabilization
• Revision of failed back surgeries (including nonunion and malunion)
• Revision of wound or hardware
• Contraindication to regional anesthesia
• Patients with chronic use of opioid medications
• Liver dysfunction (INR > 1.5, albumin <2.8g/dl, bilirubin >2mg/dl)
• Renal dysfunction (eGFR < 60ml/min/1.73m2)
• Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation
• Unable to give informed consent
• Pregnancy

Where it is running

• Missouri Orthopaedic Institute — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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