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).
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: 1. Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone. 2. Shorter hospital stay compared to participants receiving only systemic dexamethasone. 3. Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
105
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
Administration of 10mg Dexamethasone IV intraoperatively
Postoperative Pain
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Time frame: 2 years postoperative
Physical Functioning
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
Time frame: 2 years postoperative
Disability
Oswestry Disability Index score as compared to preoperative score
Time frame: 2 years postoperative
General health status
Short Form-12 Survey scores as compared to preoperative value
Time frame: 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
Time frame: 1 week 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
Intra-operative adverse events
Blood loss, length of surgery, procedural details, complications
Time frame: 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
Time frame: 1 week postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.