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Recruiting NCT04066296

Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Phase II Interventional Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liposomal bupivacaine.
Who it may be relevant to
Registry conditions: Lumbar Spinal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Overview

Evaluate the benefit of using liposomal bupivicaine in lumbar laminectomies in terms of length of stay, IV narcotic use, 30-day narcotic use, visual analog score (VAS) and 30-day readmissions

Detailed description

Recent evidence suggests the use of liposomal bupivicaine (LB) in lumbar spine surgery shortens length of hospital stay and overall post-operative narcotic use. Studies have shown its utility in single level microdiscectomies and lumbar fusions, but there have been no publications regarding lumbar laminectomies and associated outcomes with LB. The investigators' hypothesis is that LB will significantly shorten inpatient stays as well as overall narcotic usage in single, double or multi-level lumbar laminectomies.

Interventions

  • Drug Liposomal bupivacaine
    Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.

Primary outcome measures

  • Overall length of hospital stay from hospital admission to hospital discharge [Time frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.]
Secondary outcome measures (4)
  • IV narcotic usage [Time frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.]
  • 30-day narcotic usage [Time frame: 30-day post surgery]
  • Change in Visual Analog Pain scale scores [Time frame: Screening, Day of Procedure, Prior to Hospital Discharge (Post-op, Up to 2 weeks), Up to 30-days post-surgery (Follow-Up#1) and up to 12-months post-op follow up]
  • 30-day readmission rates [Time frame: Day 30]

Eligibility criteria

Inclusion criteria

  • Male or Female
  • Adult (≥18 yo)
  • Lumbar stenosis

Exclusion criteria

  • Co-morbidities precluding surgery
  • ≤18 yo
  • Pregnant
  • Breastfeeding
  • Need for instrumented fusion
  • Prisoners
  • Intra-operative CSF leak (identified by gush of CSF)
  • Daily pre-operative opioid use of > 25 morphine Eq/day
  • Previous lumbar surgery at indicated level

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT04066296 · 19-0903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗