Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
NCT ID: NCT04182997
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2019-11-21
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo Group
Patients in this group will be given the placebo (sterile saline).
saline 0.9%
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Dexamethasone Group
Patients in this group will be given the study drug (dexamethasone).
Dexamethasone
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
Interventions
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Dexamethasone
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
saline 0.9%
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Don Moore, MD
Assistant Professor, Orthopedic Surgery
Principal Investigators
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Don Kim Moore, MD
Role: PRINCIPAL_INVESTIGATOR
Missouri Orthopaedic Institute
Locations
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Missouri Orthopaedic Institute
Columbia, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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. doi: 10.1097/00024720-200208000-00002.
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.
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.
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.
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. doi: 10.1097/00007632-200202150-00003.
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.
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.
Other Identifiers
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2014147
Identifier Type: -
Identifier Source: org_study_id
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