Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

NCT04182997 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2014147
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

• Post Operative Pain Scores

  Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.

  Until final follow up (up to 8 weeks)

• Post Operative Oswestry Disability Index

  Comparing post operative disability scores between treatment and placebo group. Using Oswestry Disability Index (ODI) to measure a patient's permanent functional disability and low back functional outcome tools.

  Until final follow up (up to 8 weeks

Secondary Outcomes (3)

• Length of stay

  Until final follow up (up to 8 weeks)

• Post Operative Opioid Usage

  Until final follow up (up to 8 weeks)

• Post Operative Complications

  Until final follow up (up to 8 weeks)

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Patients in this group will be given the placebo (sterile saline).

Drug: saline 0.9%

Dexamethasone Group

ACTIVE COMPARATOR

Patients in this group will be given the study drug (dexamethasone).

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.

Also known as: Decadron

Dexamethasone Group

saline 0.9% DRUG

Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.

Also known as: sterile saline

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
• Diagnosis of or symptoms concerning for cauda equina syndrome

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65202, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 26424336 BACKGROUND

• 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.

  PMID: 24916651 BACKGROUND

• 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.

  PMID: 29845327 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.

  PMID: 12177541 BACKGROUND

• 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.

  PMID: 21841518 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.

  PMID: 24885519 BACKGROUND

• 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. doi: 10.1097/01.brs.0000257541.91728.a1.

  PMID: 17413463 BACKGROUND

• Karst M, Kegel T, Lukas A, Ludemann 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. doi: 10.1227/01.neu.0000073530.81765.6b.

  PMID: 12925248 BACKGROUND

• 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.

  PMID: 28962912 BACKGROUND

• 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.

  PMID: 30059778 BACKGROUND

• 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. doi: 10.1097/00007632-200202150-00003.

  PMID: 11840097 BACKGROUND

• Rasmussen S, Krum-Moller DS, Lauridsen LR, Jensen SE, Mandoe 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.

  PMID: 18758356 BACKGROUND

• 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.

  PMID: 25996534 BACKGROUND

• 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.

  PMID: 29102751 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Dexamethasone; Calcium Dobesilate; Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Don Kim Moore, MD

  Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vickci Jones, MEd, CCRP

CONTACT

(573) 882-7583; jonesvicki@health.missouri.edi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to which arm they were assigned. This will be accomplished by the research coordinator determining the randomization status and passing this information along to a surgical nursing staff. The nurse will the procure either the placebo or treatment drug and give it to the treating physician and announce which treatment drug the patient is receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgery

Model Details: Patients will be randomly assigned to either the treatment group or the placebo group. At the end of surgery patients in the treatment group will have the surgical site lavaged with dexamethasone while patients in the placebo group will have the surgical site lavaged by sterile saline.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: November 21, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)