Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery

  • End date
    Dec 23, 2024
  • participants needed
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 23 October 2022


This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.


This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

Condition Lumbar Radiculopathy
Treatment Liposomal bupivacaine, Bupivacaine
Clinical Study IdentifierNCT05417113
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Adults aged greater than or equal to 18 years old and less than or equal to 85 years old
Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent

Exclusion Criteria

Patients with a history of chronic opioid use for > 3 months including but not limited to fentanyl, morphine, oxycodone, methadone
Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications
Patients with a history of alcohol or drug abuse
Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency
Patients with renal insufficiency
Patients who are pregnant
Patients with American Society of Anesthesiologists physical status of 4 or greater
Patients on immunosuppressive therapy. Pregnant patients
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