|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 February 2023 |
|
Main ID: |
NCT04066296 |
|
Date of registration:
|
03/07/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
|
|
Scientific title:
|
A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine |
|
Date of first enrolment:
|
September 8, 2019 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04066296 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jen Maitlen, BSN |
|
Address:
|
|
|
Telephone:
|
303-724-1995 |
|
Email:
|
jennifer.maitlen@cuanschutz.edu |
|
Affiliation:
|
|
|
|
Name:
|
Jens-Peter Witt, MD, PhD |
|
Address:
|
|
|
Telephone:
|
303-724-2306 |
|
Email:
|
peter.witt@cuanschutz.edu |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Lumbar Spinal Stenosis
|
|
Intervention(s)
|
|
Drug: Liposomal bupivacaine
|
|
Primary Outcome(s)
|
|
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.]
|
|
Secondary Outcome(s)
|
|
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]
|
|
30-day narcotic usage
[Time Frame: 30-day post surgery]
|
|
IV narcotic usage
[Time Frame: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|