Lumbar Spinal StenosisPhase 2NCT04066296
Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
A Phase 2 study testing Liposomal bupivacaine in people with Lumbar Spinal Stenosis, run by University of Colorado, Denver at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2019to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Adult (≥18 yo)
- Lumbar stenosis
Who cannot join
- Co-morbidities precluding surgery
- ≤18 yo
- Pregnant
- Breastfeeding
- Need for instrumented fusion
- Prisoners
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Jen Maitlen, BSN, 303-724-1995, jennifer.maitlen@cuanschutz.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Liposomal bupivacaine
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called standard local anesthetic
Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivicaine | Active comparator | Treatment with liposomal bupivicaine Receives: Drug: Liposomal bupivacaine |
| Standard Local Anesthestic | Active comparator | Treatment with Standard Local Anesthestic Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall length of hospital stay from hospital admission to hospital discharge
Length of stay will be measured in hours
Measured: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Secondary outcomes (4)
IV narcotic usage
Tracked by patient's electronic medical record
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start8 Sep 2019
- Primary completion31 Dec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066296
- Sponsor's protocol ID
- 19-0903
- Status last verified
- Sep 2024
- First submitted
- 3 Jul 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
- ClinicalTrials.gov ID
- NCT04066296
- Acronym / sponsor ID
- 19-0903
- Conditions
- Lumbar Spinal Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomized
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivicaine | Active comparator | Drug: Liposomal bupivacaineTreatment with liposomal bupivicaine |
| Standard Local Anesthestic | Active comparator | Drug: Liposomal bupivacaineTreatment with Standard Local Anesthestic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- Adult (≥18 yo)
- Lumbar stenosis
Key exclusion criteria (9 listed)
- Co-morbidities precluding surgery
- ≤18 yo
- Pregnant
- Breastfeeding
- Need for instrumented fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: standard local anestheticInjection of either liposomal bupivicaine or standard local anesthetic during surgical procedure. | Drug | Liposomal Bupivicaine, Standard Local Anesthestic |
Primary outcome
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.
Length of stay will be measured in hours
4 secondary outcomes
IV narcotic usage
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
30-day narcotic usage
Time frame: 30-day post surgery
Change in Visual Analog Pain scale scores
Time frame: 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
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal bupivacaine in people with Lumbar Spinal Stenosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens-Peter Witt, MD, PhD (303-724-2306, peter.witt@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.