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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04066296
Other study ID # 19-0903
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 8, 2019
Est. completion date January 2024

Study information

Verified date February 2023
Source University of Colorado, Denver
Contact Jens-Peter Witt, MD, PhD
Phone 303-724-2306
Email peter.witt@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall length of hospital stay from hospital admission to hospital discharge Length of stay will be measured in hours From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Secondary IV narcotic usage Tracked by patient's electronic medical record From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Secondary 30-day narcotic usage Narcotic usage will be assessed via state narcotic databases. 30-day post surgery
Secondary 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. 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
Secondary 30-day readmission rates Occurrences of readmission will be tracked by patient's electronic medical record Day 30
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