Lumbar Disc HerniationPhase 4Intra-OpNCT04182997
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
A Phase 4 study testing Dexamethasone and saline 0.9% in people with Lumbar Disc Herniation, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Dexamethasone and saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Missouri Orthopaedic Institute
Columbia, Missouri, 65202
Vicki Jones, MEd,CCRP, 573-882-7583, jonesvicki@health.missouri.edi
Don Moore, MD
About this study
Official title: Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
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.
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Dexamethasone, saline 0.9%
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
saline 0.9%Drug
Also called sterile saline
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Patients in this group will be given the placebo (sterile saline). Receives: Drug: saline 0.9% |
| Dexamethasone Group | Active comparator | Patients in this group will be given the study drug (dexamethasone). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until final follow up (up to 8 weeks
Secondary outcomes (3)
Length of stay
Determining how long patient is in hospital
Measured: Until final follow up (up to 8 weeks)
Post Operative Opioid Usage
comparing opioid usage post operatively
Measured: Until final follow up (up to 8 weeks)
Post Operative Complications
comparing rate of post-op infections
Measured: Until final follow up (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start21 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Moore, MD, University of Missouri-Columbia
- Investigators
- Don Kim Moore, MD, Principal investigator, Missouri Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182997
- Sponsor's protocol ID
- 2014147
- Acronym
- Intra-Op
- Status last verified
- May 2026
- First submitted
- 25 Nov 2019
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26424336Aljabi 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.
PubMed 24916651Arirachakaran 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.
PubMed 29845327Debi 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.
PubMed 12177541Diaz 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.
PubMed 21841518Jamjoom 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.
PubMed 24885519Jirarattanaphochai 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.
PubMed 17413463Karst 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.
PubMed 12925248Kennedy 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.
PubMed 28962912Keorochana 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.
PubMed 30059778Mirzai 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.
PubMed 11840097Rasmussen 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.
PubMed 18758356Shin 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.
PubMed 25996534Wilson-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.
PubMed 29102751