Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

Overview

The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.

Full Title of Study: “Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? – A Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2020

Detailed Description

Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve root inflammation to determine if this subjective assessment is an adequate indicator for response to epidural steroids following discectomy. Patients will be allocated randomly preoperatively to the intervention group versus control group. Pictures of the spinal cord and associated nerve root will be captured intraoperatively. These pictures will be scrutinized postoperatively and an inflammation grade will be assigned. The investigators will then identify if nerve roots with a higher-grade of inflammation respond differently to epidural steroid administration when compared to lesser-grades of inflammation. This will be measured with the a variety of outcome measures.

Interventions

  • Drug: Dexamethasone
    • Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
  • Drug: saline 0.9%
    • Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo Group
    • Patients in this group will be given the placebo (sterile saline).
  • Active Comparator: Dexamethasone Group
    • Patients in this group will be given the study drug (dexamethasone).

Clinical Trial Outcome Measures

Primary Measures

  • Post Operative Pain Scores
    • Time Frame: Until final follow up (up to 8 weeks)
    • Comparing post operative pain scores between treatment and placebo group. Using VAS pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.

Secondary Measures

  • Length of stay
    • Time Frame: Until final follow up (up to 8 weeks)
    • Determining how long patient is in hospital
  • Post Operative Opioid Usage
    • Time Frame: Until final follow up (up to 8 weeks)
    • comparing opioid usage post operatively
  • Post Operative Complications
    • Time Frame: Until final follow up (up to 8 weeks)
    • comparing rate of post-op infections

Participating in This Clinical Trial

Inclusion Criteria

  • Presenting to the University of Missouri hospital system – including the University of Missouri Hospital and Missouri Orthopaedic Institute – with a clinical assessment indicative of a lumbar disc herniation
  • Failed conservative treatment – rest, anti-inflammatory medications, physical therapy
  • Radiculopathy present – positive tension signs or sensory/motor neurologic deficits present
  • Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation

Exclusion Criteria

  • Concomitant spinal stenosis, segmental instability, or spondylolisthesis
  • Previous surgery at the affected level or recurrent herniation
  • Underlying disease that may affect response to steroids – immunocompromise, use of chronic steroids or immunosuppression
  • Pregnancy – qualitative beta hCG testing will be performed prior to enrollment
  • Diagnosis of or symptoms concerning for cauda equina syndrome

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Missouri-Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Don Moore, Assistant Professor, Orthopedic Surgery – University of Missouri-Columbia
  • Overall Contact(s)
    • Stacee Clawson, BSN, RN, (573) 884-9017, clawsons@health.missouri.edu

Citations Reporting on Results

Akinduro OO, Miller BA, Haussen DC, Pradilla G, Ahmad FU. Complications of intraoperative epidural steroid use in lumbar discectomy: a systematic review and meta-analysis. Neurosurg Focus. 2015 Oct;39(4):E12. doi: 10.3171/2015.7.FOCUS15269. Review.

Aljabi Y, El-Shawarby A, Cawley DT, Aherne T. Effect of epidural methylprednisolone on post-operative pain and length of hospital stay in patients undergoing lumbar microdiscectomy. Surgeon. 2015 Oct;13(5):245-9. doi: 10.1016/j.surge.2014.03.012. Epub 2014 Jun 7.

Arirachakaran A, Siripaiboonkij M, Pairuchvej S, Setrkraising K, Pruttikul P, Piyasakulkaew C, Kongtharvonskul J. Comparative outcomes of epidural steroids versus placebo after lumbar discectomy in lumbar disc herniation: a systematic review and meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1589-1599. doi: 10.1007/s00590-018-2229-4. Epub 2018 May 29.

Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6.

Diaz RJ, Myles ST, Hurlbert RJ. Evaluation of epidural analgesic paste components in lumbar decompressive surgery: a randomized double-blind controlled trial. Neurosurgery. 2012 Feb;70(2):414-23; discussion 423-4. doi: 10.1227/NEU.0b013e3182315f05.

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. Review.

Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617.

Karst M, Kegel T, Lukas A, Lüdemann W, Hussein S, Piepenbrock S. Effect of celecoxib and dexamethasone on postoperative pain after lumbar disc surgery. Neurosurgery. 2003 Aug;53(2):331-6; discussion 336-7.

Kennedy DJ, Zheng PZ, Smuck M, McCormick ZL, Huynh L, Schneider BJ. A minimum of 5-year follow-up after lumbar transforaminal epidural steroid injections in patients with lumbar radicular pain due to intervertebral disc herniation. Spine J. 2018 Jan;18(1):29-35. doi: 10.1016/j.spinee.2017.08.264. Epub 2017 Sep 28.

Keorochana G, Pairuchvej S, Setrkraising K, Arirachakaran A, Kongtharvonskul J. Comparative Outcomes of Perioperative Epidural Steroids After Percutaneous Endoscopic Lumbar Discectomy for Lumbar Disc Herniation: A Randomized Placebo-Controlled Trial. World Neurosurg. 2018 Nov;119:e244-e249. doi: 10.1016/j.wneu.2018.07.122. Epub 2018 Jul 27.

Mirzai H, Tekin I, Alincak H. Perioperative use of corticosteroid and bupivacaine combination in lumbar disc surgery: a randomized controlled trial. Spine (Phila Pa 1976). 2002 Feb 15;27(4):343-6.

Rasmussen S, Krum-Møller DS, Lauridsen LR, Jensen SE, Mandøe H, Gerlif C, Kehlet H. Epidural steroid following discectomy for herniated lumbar disc reduces neurological impairment and enhances recovery: a randomized study with two-year follow-up. Spine (Phila Pa 1976). 2008 Sep 1;33(19):2028-33. doi: 10.1097/BRS.0b013e3181833903.

Shin SH, Hwang BW, Keum HJ, Lee SJ, Park SJ, Lee SH. Epidural Steroids After a Percutaneous Endoscopic Lumbar Discectomy. Spine (Phila Pa 1976). 2015 Aug 1;40(15):E859-65. doi: 10.1097/BRS.0000000000000990.

Wilson-Smith A, Chang N, Lu VM, Mobbs RJ, Fadhil M, Lloyd D, Kim S, Phan K. Epidural Steroids at Closure After Microdiscectomy/Laminectomy for Reduction of Postoperative Analgesia: Systematic Review and Meta-Analysis. World Neurosurg. 2018 Feb;110:e212-e221. doi: 10.1016/j.wneu.2017.10.133. Epub 2017 Nov 1. Review.

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