Lumbar Disc Herniation, Degenerative Disc Disease, Spondylolisthesis
Conditions
Brief summary
This is a randomized prospective study that will compare the use of narcotics in a control group of non-injected patients with a treatment arm of patients injected intra-operatively with a ropivacaine, morphine, and epinephrine cocktail. The investigators hypothesize that this treatment will reduce narcotic use in patients during their hospital stay, and possibly decrease the length of their stay in the hospital.The investigators also hope their pain will be decreased as displayed by their multi-daily Clinically Aligned Pain Assessment (CAPA) score.
Interventions
DRUGMorphine
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
DRUGEpinephrine
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
DRUGnaropin
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single blind study in which participants are unaware of whether or not they received a peri-incisional injection of pain medication during their surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any adult patient 18 years of age and older who is undergoing surgery for a lumbar spine problem. Common diagnoses in this category would include lumbar disc herniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustive list.
Exclusion criteria
* Patients with comorbidities excluding use of proposed injection. * Patients with major head trauma such that they cannot provide consent or describe their post-operative pain. * Patients with other surgical treatment during study treatment (i.e. more than 1 surgery during the study period or within 30 days prior to surgery). * Pregnant women (as assessed by pre-operative pregnancy test, which is standard of care). * Patients with dementia such that they cannot provide consent or describe their post-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 to the pelvis, or with surgeries that cross the thoracolumbar junction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative narcotic use | Up to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' self-reported pain (CAPA) scores | Up to 6 weeks | Evaluates * intensity of pain * effect of pain on functionality * effect of pain on sleep * efficacy of therapy * progress toward comfort |
| Length of hospital stay | Up to 6 weeks | — |
Countries
United States
Outcome results
None listed