Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Drug: Liposomal bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded, randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivicaine<br>Treatment with liposomal bupivicaine | Drug: Liposomal bupivacaine<br>* Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.<br>* Other names: standard local anesthetic;|
| Active Comparator: Standard Local Anesthestic<br>Treatment with Standard Local Anesthestic | Drug: Liposomal bupivacaine<br>* Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.<br>* Other names: standard local anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 30-day narcotic usage | Narcotic usage will be assessed via state narcotic databases. | 30-day post surgery | 
| 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 | 
| 30-day readmission rates | Occurrences of readmission will be tracked by patient's electronic medical record | Day 30 |