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.
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: 1. Reduced incidence and duration of postoperative pain and neurologic injury 2. Shorter hospital stay 3. Better short- and long-term outcomes The study also aims to answer the following questions: 1. Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo? 2. Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo? 3. Is local corticosteroid therapy associated with improved short and long-term outcomes?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
Administration of saline at surgical site prior to incision closure
Rush University Medical Center
Chicago, Illinois, United States
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.
Time frame: 2 year postoperative
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2 year postoperative
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
Time frame: 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
Time frame: 1 week postoperative
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