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NCT Number: NCT04066296

Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

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

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Jen Maitlen, BSN

CONTACT

[email protected]

303-724-1995

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Liposomal bupivacaine

Drug

Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.

Other names: standard local anesthetic

Primary outcomes

  1. 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.

    Length of stay will be measured in hours

Secondary outcomes

  1. IV narcotic usage

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.

    Tracked by patient's electronic medical record

  2. 30-day narcotic usage

    Time frame: 30-day post surgery

    Narcotic usage will be assessed via state narcotic databases.

  3. 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

    The scale is called the Visual Analog Pain scale. This scale provides a measure of the patient's reported level of pain . Patients will be asked to rate their pain level using the Visual Analog Pain scale. This scale uses numbers, 1-10, with 1 being no pain and 10 being the worst pain. It also uses faces depicting no pain up to the worst pain. Lower reported scores indicate the patient has little to no pain, which is desirable.

  4. 30-day readmission rates

    Time frame: Day 30

    Occurrences of readmission will be tracked by patient's electronic medical record

Study contacts

Contact information is provided by the study sponsor or research team.

Akal Sethi, MD

CONTACT

[email protected]

303-724-1995

Jens-Peter Witt, MD, PhD

CONTACT

[email protected]

303-724-2306

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 26, 2019
Registry last updated
Oct 1, 2024

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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