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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Depomedrol plus IV dexamethasone | Active Comparator | Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone |
|
| IV dexamethasone | Placebo Comparator | Standard systemic (IV) dexamethasone only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed | 2 years postoperative |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Kern Singh, MD | Rush University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19023571 | Background | Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21. | |
| 21417699 | Background | McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18. |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Dexamethasone | Drug | Administration of 10mg Dexamethasone IV intraoperatively |
|
| 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 |
| 21121754 | Background | Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796. |
| 24885519 | Background | Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146. |
| 12177541 | Background | Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002. |
| 30497132 | Derived | Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584. Print 2019 Feb 1. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |