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Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066296
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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
Lumbar Spinal Stenosis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: standard local anesthetic




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066296


Contacts
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Contact: Jens-Peter Witt, MD, PhD 303-724-2306 peter.witt@cuanschutz.edu
Contact: Akal Sethi, MD 303-724-1995 akal.sethi@cuanschutz.edu

Sponsors and Collaborators
University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04066296    
Other Study ID Numbers: 19-0903
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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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:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents