Degenerative Disc Disease, Herniated Nucleus Pulposus, Myelopathy, Myeloradiculopathy, Radiculopathy, Spondylosis, Stenosis
Conditions
Brief summary
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
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?
Interventions
DRUGMethylprednisolone
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
DRUGSaline
Administration of saline at surgical site prior to incision closure
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 2 year postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 2 year postoperative | 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. |
| General health status | 2 year postoperative | 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 |
| Physical Functioning | 2 year postoperative | 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. |
| Length of Stay | 1 week postoperative | The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria |
| Post-operative adverse events | 1 week postoperative | Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU |
| Narcotic Consumption | 2 year postoperative | The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents |
Countries
United States
Outcome results
None listed