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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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