Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Last updated: December 6, 2024
Sponsor: Allina Health System
Overall Status: Suspended

Phase

4

Condition

Spondylolisthesis

Spinal Stenosis

Ankylosing Spondylitis

Treatment

Liposomal bupivacaine

Clinical Study ID

NCT03745040
1252230
  • Ages > 18
  • All Genders

Study Summary

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/orspondylolisthesis excluding degenerative disc disease

  • Receives open, one-level posterior spinal fusion

Exclusion

Exclusion Criteria:

  • Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer,at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oraloxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or anequianalgesic dose of another opioid.

  • Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra-and post-operative data will be excluded from the analysis for these patients.

  • Has severe liver disease. Bupivacaine is primarily metabolized in the liver viaconjugation with glucuronic acid. Patients with liver disease, especially severedisease may be more susceptible to toxicity.

  • Has severe renal disease. Bupivacaine and the metabolite are primarily excreted bythe kidneys. Excretion can be significantly changed by urinary perfusion, thepresence of renal disease, factors affecting urinary pH, and renal blood flow

  • Is less than 18 years old.

  • Is pregnant.

  • Cannot read and speak English.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Liposomal bupivacaine
Phase: 4
Study Start date:
January 26, 2019
Estimated Completion Date:
August 31, 2028

Study Description

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).

Connect with a study center

  • Abbott Northwestern Hospital, Allina Health System

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • United Hospital, Allina Health System

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

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