Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

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

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Drug: Liposomal bupivacaine

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jens-Peter Witt, MD, PhD; Phone Number: 303-724-2306; Email: peter.witt@cuanschutz.edu
• Study Contact Backup: Name: Akal Sethi, MD; Phone Number: 303-724-1995; Email: akal.sethi@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Jen Maitlen, BSN; Phone Number: 303-724-1995; Email: jennifer.maitlen@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Liposomal Bupivicaine; Treatment with liposomal bupivicaine	Drug: Liposomal bupivacaine; Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.; Other Names: standard local anesthetic
ACTIVE_COMPARATOR: Standard Local Anesthestic; Treatment with Standard Local Anesthestic	Drug: Liposomal bupivacaine; Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.; Other Names: standard local anesthetic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2019
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 19-0903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No