Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
Study Overview
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:
- 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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
Local injection of methylprednisolone
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
Intervention: Methylprednisolone (Drug)
Local injection of saline
Administration of saline at surgical site prior to incision closure.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 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 Outcomes
- Disability(2 year postoperative)
- Narcotic Consumption(2 year postoperative)
- Length of Stay(1 week postoperative)
- General health status(2 year postoperative)
- Physical Functioning(2 year postoperative)
- Post-operative adverse events(1 week postoperative)
Investigators
Kern Singh
Professor, Department of Orthopaedic Surgery
Rush University Medical Center