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Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Primary Purpose

Lumbar Spinal Stenosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liposomal Bupivicaine

Standard Local Anesthestic

Arm Description

Treatment with liposomal bupivicaine

Treatment with Standard Local Anesthestic

Outcomes

Primary Outcome Measures

Overall length of hospital stay from hospital admission to hospital discharge
Length of stay will be measured in hours

Secondary Outcome Measures

IV narcotic usage
Tracked by patient's electronic medical record
30-day narcotic usage
Narcotic usage will be assessed via state narcotic databases.
Change in Visual Analog Pain scale scores
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.
30-day readmission rates
Occurrences of readmission will be tracked by patient's electronic medical record

Full Information

First Posted
July 3, 2019
Last Updated
February 2, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04066296
Brief Title
Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
Official Title
A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The PI, co-Investigators, and clinicians will be blinded to the patient's treatment arm. The pharmacist will be unblinded.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivicaine
Arm Type
Active Comparator
Arm Description
Treatment with liposomal bupivicaine
Arm Title
Standard Local Anesthestic
Arm Type
Active Comparator
Arm Description
Treatment with Standard Local Anesthestic
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
standard local anesthetic
Intervention Description
Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.
Primary Outcome Measure Information:
Title
Overall length of hospital stay from hospital admission to hospital discharge
Description
Length of stay will be measured in hours
Time Frame
From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Secondary Outcome Measure Information:
Title
IV narcotic usage
Description
Tracked by patient's electronic medical record
Time Frame
From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Title
30-day narcotic usage
Description
Narcotic usage will be assessed via state narcotic databases.
Time Frame
30-day post surgery
Title
Change in Visual Analog Pain scale scores
Description
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.
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
Title
30-day readmission rates
Description
Occurrences of readmission will be tracked by patient's electronic medical record
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens-Peter Witt, MD, PhD
Phone
303-724-2306
Email
peter.witt@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Akal Sethi, MD
Phone
303-724-1995
Email
akal.sethi@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen Maitlen, BSN
Phone
303-724-1995
Email
jennifer.maitlen@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.

Learn more about this trial

Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

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