Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066296
• Other study ID #: 19-0903
• Status: Recruiting
• Phase: Phase 2
• Start date: September 8, 2019
• Est. completion date: January 2024

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: Jens-Peter Witt, MD, PhD
• Phone: 303-724-2306
• Email: peter.witt[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Drug:
• Liposomal bupivacaine
Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	30-day narcotic usage	Narcotic usage will be assessed via state narcotic databases.	30-day post surgery
Secondary	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
Secondary	30-day readmission rates	Occurrences of readmission will be tracked by patient's electronic medical record	Day 30