Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Lumbar Spinal Stenosis

Treatments: Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04066296

19-0903

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Liposomal Bupivicaine

Active Comparator group

Description:

Treatment with liposomal bupivicaine

Treatment:

Drug: Liposomal bupivacaine

Standard Local Anesthestic

Active Comparator group

Description:

Treatment with Standard Local Anesthestic

Treatment:

Drug: Liposomal bupivacaine