Peri-Incisional Drug Injection in Lumbar Spine Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery

Conditions
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Lumbar Disc Herniation, Degenerative Disc Disease, Spondylolisthesis

Intervention / Treatment
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* Drug: Morphine
* Drug: Epinephrine
* Drug: naropin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar Spine Surgery with Injection<br>Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery. | Drug: Morphine<br>* Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.<br>Drug: Epinephrine<br>* Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.<br>Drug: naropin<br>* Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.<br>|
| No Intervention: Lumbar Spine Surgery without Injection<br>Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative narcotic use |  | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' self-reported pain (CAPA) scores | Evaluates intensity of pain effect of pain on functionality effect of pain on sleep efficacy of therapy progress toward comfort | Up to 6 weeks | 
| Length of hospital stay |  | Up to 6 weeks |