Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

NCT ID: NCT04066296

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-08

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The PI, co-Investigators, and clinicians will be blinded to the patient's treatment arm. The pharmacist will be unblinded.

Study Groups

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Liposomal Bupivicaine

Treatment with liposomal bupivicaine

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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

Standard Local Anesthestic

Treatment with Standard Local Anesthestic

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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

Interventions

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Liposomal bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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standard local anesthetic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jens-Peter Witt, MD, PhD

Role: CONTACT

303-724-2306

Akal Sethi, MD

Role: CONTACT

303-724-1995

Facility Contacts

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Jen Maitlen, BSN

Role: primary

303-724-1995

Other Identifiers

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19-0903

Identifier Type: -

Identifier Source: org_study_id

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