Last updated: August 16, 2022
Sponsor: University of Minnesota
Overall Status: Trial Not Available
Phase
3
Condition
Spondylolisthesis
Ankylosing Spondylitis
Radiculopathy
Treatment
N/AClinical Study ID
NCT03513445
ORSU-2018-26340
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Any adult patient 18 years of age and older who is undergoing surgery for a lumbarspine problem. Common diagnoses in this category would include lumbar discherniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustivelist.
Exclusion
Exclusion Criteria:
- Patients with comorbidities excluding use of proposed injection.
- Patients with major head trauma such that they cannot provide consent or describetheir post-operative pain.
- Patients with other surgical treatment during study treatment (i.e. more than 1surgery during the study period or within 30 days prior to surgery).
- Pregnant women (as assessed by pre-operative pregnancy test, which is standard ofcare).
- Patients with dementia such that they cannot provide consent or describe theirpost-operative pain.
- Patients with an allergy to study medications.
- Patients with previous drug dependencies.
- Any patient that refuses to be randomized or does not wish to enroll.
- Vulnerable populations, such as prisoners.
- Patients with a fracture, tumor, or infection as their primary diagnosis.
- Patients undergoing a deformity correction.
- Patients with surgeries extending more than 4 levels, with surgeries that extend tothe pelvis, or with surgeries that cross the thoracolumbar junction.
Study Design
Study Start date:
June 01, 2018
Estimated Completion Date:
September 30, 2022
Connect with a study center
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
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