Recruiting
Phase 2

Liposomal Bupivicaine

Sponsor:

University of Colorado, Denver

Code:

NCT04066296

Conditions

Lumbar Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal bupivacaine

Study Details

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

Study ID

NCT04066296

Start date

Sep 8, 2019

Status verified date

Sep, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Liposomal Bupivicaine

Treatment with liposomal bupivicaine

active comparator: Standard Local Anesthestic

Treatment with Standard Local Anesthestic

Interventions

Liposomal bupivacaine

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

Primary outcome measure

  • Overall length of hospital stay from hospital admission to hospital discharge [ Time Frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks. ]

Central Contacts and Locations

Central contacts

Jens-Peter Witt, MD, PhD

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

Akal Sethi, MD

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

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jen Maitlen, BSN

303-724-1995jennifer.maitlen@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-01.