Use of Local Intraoperative Steroid in MIS TLIF

Study Overview
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Brief Summary
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The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).

Detailed Description
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Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients. The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF. The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have: Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone. Shorter hospital stay compared to participants receiving only systemic dexamethasone. Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone

Official Title
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Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion

Conditions
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Dysphasia

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a primary 1- to 2-level MIS TLIF 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: (a) Existing history of gastrointestinal bleeding Current Smokers Lumbar spine trauma Bilateral cages Lack of consent
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 Depomedrol plus IV dexamethasone<br>Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone | Drug: Methylprednisolone<br>* Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure<br>Drug: Dexamethasone<br>* Administration of 10mg Dexamethasone IV intraoperatively<br>|
| Placebo Comparator: IV dexamethasone<br>Standard systemic (IV) dexamethasone only | Drug: Dexamethasone<br>* Administration of 10mg Dexamethasone IV intraoperatively<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 Back and Leg score from preoperative value will be assessed | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Functioning | Patient-Reported Outcomes Measurement Information System score as compared to preoperative value | 2 years postoperative | 
| Disability | Oswestry Disability Index score as compared to preoperative score | 2 years postoperative | 
| General health status | Short Form-12 Survey scores as compared to preoperative value | 2 years postoperative | 
| Narcotic Consumption | The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents | 1 week 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 | 
| Intra-operative adverse events | Blood loss, length of surgery, procedural details, complications | day of surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transforaminal lumbar interbody fusion, methylprednisolone