Lumbar Spinal Stenosis
Conditions
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.
Interventions
DRUGLiposomal bupivacaine
Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Double blinded, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 30-day narcotic usage | 30-day post surgery | Narcotic usage will be assessed via state narcotic databases. |
| 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. |
| 30-day readmission rates | Day 30 | Occurrences of readmission will be tracked by patient's electronic medical record |
Countries
United States
Contacts
Primary ContactJens-Peter Witt, MD, PhD
Backup ContactAkal Sethi, MD
Outcome results
None listed