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Completed

NCT Number: NCT04644796

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

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

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Key information

Conditions

Lumbar Spine Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saline 0.9%

Drug

Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.

Other names: sterile saline

Liposomal bupivacaine

Drug

Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.

Other names: Exparel

Primary outcomes

  1. Postoperative Opioid Utilization

    Time frame: Until final follow-up, up to 8 weeks.

    Comparing post operative opioid usage reduction between treatment and placebo group.

Secondary outcomes

  1. Post Operative Pain Scores

    Time frame: Until final follow-up or up to 8 weeks after surgery date, whichever comes first.

    Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.

  2. Length of Stay

    Time frame: Until final follow-up, up to 8 weeks.

    Determining how long patient is in hospital.

  3. Operative Data and Complications

    Time frame: Until final follow-up, up to 8 weeks.

    Comparing intraoperative complications, acute postoperative complication, and opioid complications.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

A Randomized Controlled Trial of the Effect of Liposomal Bupivacaine (Exparel) When Compared to Saline Control in Reducing Opioid Utilization for Pain Management in Postoperative Lumbar Spine Surgeries.

Acronym: Exparel

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2020
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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