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Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04066296
Collaborator
(none)
100
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal bupivacaine
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blinded, randomizedDouble blinded, randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The PI, co-Investigators, and clinicians will be blinded to the patient's treatment arm. The pharmacist will be unblinded.
Primary Purpose:
Treatment
Official Title:
A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Liposomal Bupivicaine

Treatment with liposomal bupivicaine

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

    		•
    Active Comparator: Standard Local Anesthestic

    Treatment with Standard Local Anesthestic

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall length of hospital stay from hospital admission to hospital discharge [From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.]

      Length of stay will be measured in hours

    Secondary Outcome Measures

    1. IV narcotic usage [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 [30-day post surgery]

      Narcotic usage will be assessed via state narcotic databases.

    3. Change in Visual Analog Pain scale scores [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 [Day 30]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or Female

    2. Adult (≥18 yo)

    3. Lumbar stenosis

    Exclusion Criteria:

    1. Co-morbidities precluding surgery

    2. ≤18 yo

    3. Pregnant

    4. Breastfeeding

    5. Need for instrumented fusion

    6. Prisoners

    7. Intra-operative CSF leak (identified by gush of CSF)

    8. Daily pre-operative opioid use of > 25 morphine Eq/day

    9. Previous lumbar surgery at indicated level

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04066296
    Other Study ID Numbers:
    • 19-0903
    First Posted:
    Aug 26, 2019
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Spinal Stenosis
    Bupivacaine
    Anesthetics, Local
    Anesthetics

    Study Results

    No Results Posted as of Feb 18, 2021