Dysphasia
Conditions
Keywords
transforaminal lumbar interbody fusion, methylprednisolone
Brief summary
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
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
Interventions
DRUGMethylprednisolone
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
DRUGDexamethasone
Administration of 10mg Dexamethasone IV intraoperatively
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 2 years postoperative | Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning | 2 years postoperative | Patient-Reported Outcomes Measurement Information System score as compared to preoperative value |
| Disability | 2 years postoperative | Oswestry Disability Index score as compared to preoperative score |
| General health status | 2 years postoperative | Short Form-12 Survey scores as compared to preoperative value |
| Length of Stay | 1 week postoperative | The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria. |
| Intra-operative adverse events | day of surgery | Blood loss, length of surgery, procedural details, complications |
| 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 | 1 week postoperative | The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents |
Outcome results
None listed