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

  • STATUS
    Recruiting
  • End date
    Jan 4, 2024
  • participants needed
    200
  • sponsor
    University of Missouri-Columbia
Updated on 4 November 2021

Summary

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

Description

Multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. Many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. Liposomal bupivacaine (LB) (Exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. LB has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. The goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital stay.

Details
Condition Lumbar Spine Degeneration
Treatment Liposomal bupivacaine, Saline 0.9%
Clinical Study IdentifierNCT04644796
SponsorUniversity of Missouri-Columbia
Last Modified on4 November 2021

Eligibility

Yes No Not Sure

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
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