Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Phase 2

Recruiting

• Conditions: Lumbar Spinal Stenosis
• Interventions: Drug: Liposomal bupivacaine

• Registration Number: NCT04066296
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2019-09-08
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivicaine	Liposomal bupivacaine	Treatment with liposomal bupivicaine
Standard Local Anesthestic	Liposomal bupivacaine	Treatment with Standard Local Anesthestic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
30-day narcotic usage	30-day post surgery	Narcotic usage will be assessed via state narcotic databases.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States