Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

NCT04066296 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 19-0903
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• IV narcotic usage

  From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.

• 30-day narcotic usage

  30-day post surgery

• 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

• 30-day readmission rates

  Day 30

Study Arms (2)

Liposomal Bupivicaine

ACTIVE COMPARATOR

Treatment with liposomal bupivicaine

Drug: Liposomal bupivacaine

Standard Local Anesthestic

ACTIVE COMPARATOR

Treatment with Standard Local Anesthestic

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.

Also known as: standard local anesthetic

Liposomal Bupivicaine; Standard Local Anesthestic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Adult (≥18 yo)
• Lumbar stenosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Jens-Peter Witt, MD, PhD

CONTACT

303-724-2306; peter.witt@cuanschutz.edu

Akal Sethi, MD

CONTACT

303-724-1995; akal.sethi@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI, co-Investigators, and clinicians will be blinded to the patient's treatment arm. The pharmacist will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded, randomized

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: August 26, 2019
• Study Start: September 8, 2019
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)