Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Study Overview
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Brief Summary
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Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.

Detailed Description
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The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF. The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have: Reduced incidence and duration of postoperative pain and neurologic injury Shorter hospital stay Better short- and long-term outcomes The study also aims to answer the following questions: Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo? Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo? Is local corticosteroid therapy associated with improved short and long-term outcomes?

Official Title
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Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Conditions
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Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease, Spondylosis, Myelopathy, Radiculopathy, Myeloradiculopathy

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a 1- to 2-level XLIF Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis Patients able to provide informed consent Exclusion Criteria: Allergies or other contraindications to medicines in the protocol including: Existing history of gastrointestinal bleeding Lumbar spine trauma Unable to speak, read, or understand English
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local injection of methylprednisolone<br>Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure | Drug: Methylprednisolone<br>* Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure<br>* Other names: Depomedrol;|
| Placebo Comparator: Local injection of saline<br>Administration of saline at surgical site prior to incision closure. | Drug: Saline<br>* Administration of saline at surgical site prior to incision closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable. | 2 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Functioning | Patient-Reported Outcomes Measurement Information System (PROMIS) physical function score as compared to preoperative value. This score assesses physical function and is scaled from 0-100 with 100 indicating greater functioning and 0 indicating worse functioning. | 2 year postoperative | 
| Disability | Oswestry Disability Index (ODI) score as compared to preoperative score. ODI assesses disability out of a total of 50 points and is scaled to a percentage of total possible points with 0 indicating no disability and 100 indicating severe disability. | 2 year postoperative | 
| General health status | Short Form (SF)-12 Survey scores as compared to preoperative values. SF-12 assesses general physical and mental health on a scale of 0 to 100 with higher scores indicating superior health status | 2 year postoperative | 
| Narcotic Consumption | The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents | 2 year postoperative | 
| Length of Stay | The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria | 1 week postoperative | 
| Post-operative adverse events | Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU | 1 week postoperative |