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Search / Trial NCT04644796

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

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Nov 19, 2020

Trial Information

Current as of August 02, 2025

Completed

Keywords

ClinConnect Summary

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....

Gender

ALL

Eligibility 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

About University Of Missouri Columbia

The University of Missouri-Columbia is a leading academic institution dedicated to advancing medical research and clinical innovation. As a prominent sponsor of clinical trials, the university leverages its extensive resources and expertise to facilitate groundbreaking studies aimed at improving patient outcomes across a variety of health conditions. With a commitment to ethical research practices and collaboration with multidisciplinary teams, the University of Missouri-Columbia strives to translate scientific discoveries into effective therapeutic interventions, ultimately enhancing the quality of care in the communities it serves.

Locations

Columbia, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Theodore Choma, MD

Principal Investigator

University of Missouri - Missouri Orthopaedic Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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